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Clinical Trials (PDQ®)

Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBehavioral study, Biomarker/Laboratory analysisActiveNot specifiedNCI, OtherGOG-0225
NCI-2009-00595, CDR0000594600, U10CA101165, NCT00719303

Trial Description

Summary

This randomized phase III trial studies diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy lifestyle and counseling after treatment may improve progression-free survival in patients with previously treated cancer.

Further Study Information

PRIMARY OBJECTIVE:

I. To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention, will have significantly increased progression-free survival compared to similar women who are randomized to a usual care comparison group.

SECONDARY OBJECTIVE:

I. To determine if women who are randomized to the study intervention will have improved general quality of life as measured by the General Health subscale of RAND 36-Item Health Survey (RAND-36).

II. To determine if women who are randomized to the study intervention will have improved physical and bowel functioning as measured by the Physical Functioning subscale of RAND-36 and the Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS), compared to women who are randomized to usual care.

TERTIARY OBJECTIVES:

I. To assess patient compliance with the healthy lifestyle intervention by analyzing biomarkers (e.g., total carotenoid) at baseline, 6, 12, and 24 months.

II. To explore the relationship between carotenoid exposure and progression free survival from ovarian cancer.

III. To examine patient compliance with the healthy lifestyle intervention and to assess which types of patients are more likely to be compliant with the healthy lifestyle intervention and whether progression-free survival is better among compliant individuals.

IV. To explore the impact of the intervention on other aspects of quality of life such as pain, role limitations due to physical health and emotional problems, mental health, vitality, and social functioning as measured by the corresponding subscales of the RAND-36.

V. To explore the impact of the intervention on bowel functioning as measured with the GSRS-IBS subscales.

VI. To assess the association between subjectively measured sleep duration/quality (using the Pittsburgh Sleep Quality Scale), anthropometric measurements, and self-reported dietary energy intake among women previously treated for stage II-IV ovarian or primary peritoneal cancer.

VII. To assess and compare telomere length and rate of telomere shortening between ovarian cancer survivors randomized to lifestyle intervention versus standard of care.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP 1: (lifestyle intervention) Participants receive a dietary intervention designed to promote increased levels of plasma carotenoids, control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen to raise the usual activity level. Participants also undergo face-to-face counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor once a week for 4 weeks, then twice a month for 6 months, monthly for the subsequent 6 months, and then once every other month for 11 months. Participants complete daily fat gram and step diaries at least three times per week.

GROUP 2: (comparison lifestyle) Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention).

After completion of study, participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma
  • Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy or biological therapy
  • Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
  • Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
  • Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization (previous 12 months)
  • Patients must complete all pre-entry assessments
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC

Exclusion Criteria:

  • Patients with GOG performance grade of 3 or 4
  • Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus
  • Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
  • Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
  • Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
  • Patients with a life expectancy of less than one year
  • Patients with Body Mass Index (BMI) < 20 kg/m^2
  • Vegan vegetarians
  • Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
  • Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
  • Patients who have had surgery for weight loss

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

David AlbertsPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Warner Huh Ph: 205-934-0309
  Huntsville
 Tennessee Valley Gynecologic Oncology
 David B Engle Ph: 256-533-6233
Arizona
  Phoenix
 St. Joseph's Hospital and Medical Center
 Dana M Chase Ph: 877-602-4111
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Alexander Ferguson Burnett Ph: 501-686-8274
California
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Babak Edraki Ph: 925-674-2580
  Duarte
 City of Hope Comprehensive Cancer Center
 Robert Joseph Morgan Ph: 800-826-4673
  Email: becomingapatient@coh.org
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 David Samuel Alberts Ph: 520-626-7685
  Email: dalberts@uacc.arizona.edu
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Scott E. Lentz Ph: 626-564-3455
 USC/Norris Comprehensive Cancer Center and Hospital
 Huyen Q Pham Ph: 323-865-0451
 Huyen Q Pham Ph: 323-865-0451
  Mountain View
 Palo Alto Medical Foundation
 Albert L Pisani Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Orange
 St. Joseph Hospital Regional Cancer Center - Orange
 Michael L Berman Ph: 877-827-8839
  Email: ucstudy@uci.edu
  Sacramento
 University of California Davis Cancer Center
 Gary Leiserowitz Ph: 916-734-3089
  San Diego
 Rebecca and John Moores UCSD Cancer Center
 Michael T. McHale Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Babak Edraki Ph: 925-674-2580
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Aurora
 Keren Sturtz Ph: 888-785-6789
 University of Colorado Cancer Center at UC Health Sciences Center
 Susan Davidson Ph: 720-848-0650
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Cynthia K. Cathcart Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Fort Collins
 Poudre Valley Hospital
 Regina J Brown Ph: 970-297-6150
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Angela S Kueck Ph: 800-579-7822
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
  New Haven
 Yale Cancer Center
 Elena S Ratner Ph: 203-785-5702
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Mark E Borowsky Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Mark E Borowsky Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Mark E Borowsky Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Mark E Borowsky Ph: 302-733-6227
 Mark E Borowsky Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Mark E Borowsky Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Mark E Borowsky Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Mark E Borowsky Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Mark E Borowsky Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Mark E Borowsky Ph: 302-733-6227
Florida
  Sarasota
 Sarasota Memorial Hospital
 James V. Fiorica Ph: 941-917-2225
Georgia
  Atlanta
 Northside Hospital Cancer Center
 Guilherme C. Cantuaria Ph: 404-303-3355
  Email: clinicaltrials@northside.com
 Piedmont Hospital
 John Warren McBroom Ph: 404-303-3355
  Email: ORS@piedmont.org
  Augusta
 Medical College of Georgia Cancer Center
 Sharad Anant Ghamande Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
  Gainesville
 Northeast Georgia Medical Center
 Andrew E Green Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 James J Burke Ph: 912-350-8568
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 William Edward Richards Ph: 800-622-6877
  Email: uchealthnews@uc.edu
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Michael E. Carney Ph: 808-983-6090
 Kapiolani Medical Center for Women and Children
 Michael E. Carney Ph: 808-983-6090
 OnCare Hawaii, Incorporated - Lusitana
 Michael E. Carney Ph: 808-983-6090
 Queen's Cancer Institute at Queen's Medical Center
 Michael E. Carney Ph: 808-983-6090
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Emily Berry Ph: 312-695-1301
  Email: cancer@northwestern.edu
 Rush Cancer Institute at Rush University Medical Center
 Alfred S Guirguis Ph: 312-942-5498
  Email: clinical_trials@rush.edu
 University of Chicago Cancer Research Center
 Meaghan E Tenney Ph: 773-834-7424
  Email: julie-traylor@ouhsc.edu
  Danville
 Carle on Vermilion
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Carle Physician Group-Effingham
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  Mattoon
 Carle Physician Group-Mattoon/Charleston
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  New Lennox
 Silver Cross Hospital
 Meaghan E Tenney Ph: 773-834-7424
  Email: julie-traylor@ouhsc.edu
  Oak Lawn
 Advocate Christ Medical Center
 Renee H. Jacobs Ph: 630-856-7526
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
 Maria T Grosse-Perdekamp Ph: 800-446-5532
  Email: kcheek@dmhhs.org
Indiana
  Elkhart
 Michiana Hematology-Oncology, PC - Elkhart
 Michael Rodriguez Ph: 574-237-1328
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Jeanne M Schilder Ph: 317-274-2552
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Michael W. Method Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Michael W. Method Ph: 574-237-1328
  South Bend
 CCOP - Northern Indiana CR Consortium
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Michael W. Method Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Michael W. Method Ph: 574-237-1328
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Julia A. Chapman Ph: 913-588-4709
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Overland Park
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Edgewood
 St. Elizabeth Medical Center
 Jack Basil Ph: 513-862-2230
  Email: darla.hehman@stelizabeth.com
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Mary E Gordinier Ph: 502-629-2500
 Norton Suburban Hospital
 Mary E Gordinier Ph: 502-629-2500
Louisiana
  Baton Rouge
 Hematology-Oncology Clinic
 William R. Robinson Ph: 504-988-6121
  New Orleans
 Tulane Cancer Center at Tulane University Hospital and Clinic
 William R. Robinson Ph: 504-988-6121
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Christopher J Darus Ph: 207-885-7565
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Paul Celano Ph: 443-849-3706
  Bethesda
 National Naval Medical Center
 Michael P Stany Ph: 301-319-2100
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Young B Kim Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Worcester
 Levine Cancer Center at UMass Medical Center - Memorial Campus
 Susan L. Zweizig Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
 University of Michigan Comprehensive Cancer Center
 Carolyn M. Johnston Ph: 734-712-3456
 David Samuel Alberts Ph: 520-626-7685
  Email: dalberts@azcc.arizona.edu
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
 Wayne State University
 Robert T. Morris Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-4673
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-4673
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-4673
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Niles
 Lakeland Hospital - Niles
 Gilbert D Padula Ph: 616-685-5225
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Michael Rodriguez Ph: 574-237-1328
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Michael Rodriguez Ph: 574-237-1328
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Minnesota
  Bemidji
 MeritCare Bemidji
 Maria C. Bell Ph: 218-333-5000
  Burnsville
 Fairview Ridges Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Health Partners Inc
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Hennepin County Medical Center - Minneapolis
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Louis Park
 Park Nicollet Cancer Center
 Michaela L Tsai Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 St. Dominic Cancer Center
 Donald P Seago Ph: 601-200-3300
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Independence
 Independence Regional Health Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Lee's Summit
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Peter C. Morris Ph: 402-354-7939
  Email: kathryn.bartz@nmhs.org
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Peter C Lim Ph: 866-513-8227
 Peter C Lim Ph: 866-513-8227
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Leslie R. DeMars Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Donna T McNamara Ph: 201-996-2879
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Nana E Tchabo Ph: 973-971-5900
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates, Incorporated
 Teresa L Rutledge Ph: 505-272-6972
 University of New Mexico Cancer Center
 Teresa L Rutledge Ph: 505-272-6972
New York
  Albany
 Women's Cancer Care Associates
 Daniel Casey Kredentser Ph: 518-458-1390
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Veena S John Ph: 516-562-3467
  New Hyde Park
 Long Island Jewish Medical Center
 Veena S John Ph: 516-562-3467
 Monter Cancer Center of the North Shore-LIJ Health System
 Veena S John Ph: 516-562-3467
  Stony Brook
 Stony Brook University Cancer Center
 Michael L. Pearl Ph: 800-862-2215
North Carolina
  Asheboro
 Randolph Hospital
 James M Granfortuna Ph: 336-832-0821
  Asheville
 Hope A Women's Cancer Center
 Timothy J Vanderkwaak Ph: 828-670-8403
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Linda Van Le Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 John M McDonald Ph: 704-384-5369
  Durham
 Duke Cancer Institute
 Laura J Havrilesky Ph: 888-275-3853
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 James M Granfortuna Ph: 336-832-0821
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 John W. Byron Ph: 910-715-2200
  Reidsville
 Annie Penn Cancer Center
 James M Granfortuna Ph: 336-832-0821
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 Maria C. Bell Ph: 218-333-5000
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Maria C. Bell Ph: 218-333-5000
 Sanford Clinic North-Fargo
 Maria C. Bell Ph: 218-333-5000
Ohio
  Canton
 Aultman Cancer Center at Aultman Hospital
 Michael P. Hopkins Ph: 330-363-6891
  Cincinnati
 Bethesda North Hospital
 James C Pavelka Ph: 513-862-2230
 Good Samaritan Hospital Cancer Treatment Center
 James C Pavelka Ph: 513-862-2230
  Cleveland
 Cleveland Clinic Cancer Center at Fairview Hospital
 Peter Graham Rose Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 Peter Graham Rose Ph: 866-223-8100
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Peter Graham Rose Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Nicholas P Taylor Ph: 610-954-3582
  Email: infolink@slhn.org
  Danville
 Geisinger Cancer Institute at Geisinger Health
 James R Bosscher Ph: 570-271-5251
  Email: ehicks@sprg.mercy.net
  Gettysburg
 Adams Cancer Center
 Mark A Miller Ph: 877-441-7957
  Email: pridgely@lifebridgehealth.org
  Hazleton
 Geisinger Hazleton Cancer Center
 James R Bosscher Ph: 570-271-5251
  Email: ehicks@sprg.mercy.net
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Stephen C. Rubin Ph: 215-728-4790
  Pittsburgh
 UPMC Cancer Centers
 Robert P. Edwards Ph: 412-647-2811
  State College
 Geisinger Medical Group - Scenery Park
 James R Bosscher Ph: 570-271-5251
  Email: ehicks@sprg.mercy.net
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 James R Bosscher Ph: 570-271-5251
  Email: ehicks@sprg.mercy.net
  York
 WellSpan Health
 Mark A Miller Ph: 877-441-7957
  Email: pridgely@lifebridgehealth.org
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Maria C. Bell Ph: 218-333-5000
 Maria C. Bell Ph: 218-333-5000
Tennessee
  Chattanooga
 Chattanooga's Program in Women's Oncology
 Stephen E DePasquale Ph: 423-266-3636
Texas
  Dallas
 Parkland Memorial Hospital
 David Scott Miller Ph: 214-648-7097
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Fort Sam Houston
 Brooke Army Medical Center
 Jason C Barnett Ph: 210-916-4837
  Houston
 Lyndon B. Johnson General Hospital
 Lois M. Ramondetta Ph: 713-792-3245
 Methodist Hospital
 Aparna A Kamat Ph: 713-790-2700
 Univeristy of Texas M.D. Anderson Cancer Center
 Diane C. Bodurka Ph: 713-792-3245
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Theresa L Werner Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Susan C Modesitt Ph: 434-243-6143
  Portsmouth
 Naval Medical Center - Portsmouth
 Michael A Bidus Ph: 757-953-5939
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Weldon E Chafe Ph: 804-628-1939
  Roanoke
 Carilion Clinic Gynecological Oncology
 Janet L. Osborne Ph: 540-985-8510
Washington
  Seattle
 CCOP - Virginia Mason Research Center
 Amy D Brockmeyer Ph: 800-354-9527
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan E Tammela Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 St. Mary's Hospital Medical Center - Green Bay
 Jonathan E Tammela Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 David M Kushner Ph: 877-405-6866
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Jonathan E Tammela Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Jonathan E Tammela Ph: 920-433-8889
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 William H Bradley Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Scott A Kamelle Ph: 414-649-7200
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Zahid N Dar Ph: 800-252-2990
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Zahid N Dar Ph: 800-252-2990
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00719303
ClinicalTrials.gov processed this data on October 19, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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