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Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, Tissue collection/RepositoryActive18 and overNCI, OtherCDR0000684240
NCCTG-N08C9, N08C9, NCT01198145

Trial Description

Summary

RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

Further Study Information

OBJECTIVES:

Primary

  • To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy.

Secondary

  • To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy.
  • To determine whether sulfasalazine causes any toxicity in this situation.

Tertiary

  • To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational)

OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs > 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.
  • Arm II: Patients receive oral placebo twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.

NOTE: *Patients must start study treatment by the third radiotherapy fraction.

Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy.

After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer that supports the use of radiotherapy to the pelvis
  • No current or prior metastases beyond pelvic regional lymph nodes
  • Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin
  • Planned course of pelvic radiotherapy must fall within the following parameters:
  • Pelvis must be encompassed by the planned radiotherapy fields
  • Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
  • Portions of the rectum may have special blocking, depending upon disease site
  • Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)*
  • Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned
  • Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis
  • Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day*
  • NOTE: *For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
  • No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
  • No brachytherapy planned before the completion of all external-beam radiotherapy
  • No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Hemoglobin ≥ 10.0 g/dL
  • Leukocytes ≥ 3,500/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
  • Able to complete questionnaires alone or with assistance
  • No history of inflammatory bowel disease
  • No history of gastrointestinal or genitourinary obstruction or porphyria
  • No history of G6PD deficiency
  • No history of irritable bowel syndrome
  • No history of blood dyscrasia
  • No history of severe allergies or asthma
  • No history of hepatic or renal disease
  • No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
  • No medical condition that may interfere with the ability to receive study treatment
  • No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
  • No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
  • No other concurrent sulfasalazine
  • No concurrent digoxin

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

National Cancer Institute

Robert C. MillerStudy Chair

James A. Martenson

Charles L. Loprinzi

Trial Sites

U.S.A.
Arizona
  Phoeniz
 Mayo Clinic Hospital
 Robert C. Miller Ph: 507-538-7623
  Scottsdale
 Mayo Clinic Scottsdale
 Robert C. Miller Ph: 507-538-7623
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Eduardo R. Pajon Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Denver
 Porter Adventist Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Rose Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 St. Anthony Central Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 St. Joseph Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Lone Tree
 Sky Ridge Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo R. Pajon Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Thornton
 North Suburban Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Georgia
  Augusta
 Medical College of Georgia Cancer Center
 Randall F. Roberts Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
  Columbus
 John B. Amos Cancer Center
 Andrew W. Pippas Ph: 706-660-6404
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
  Honolulu
 Cancer Research Center of Hawaii
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Hawaii Medical Center - East
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Kapiolani Medical Center for Women and Children
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 OnCare Hawaii, Incorporated - Kuakini
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 OnCare Hawaii, Incorporated - Lusitana
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Queen's Cancer Institute at Queen's Medical Center
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Straub Clinic and Hospital, Incorporated
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Tripler Army Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Ronald A Sapiente Ph: 800-446-5532
  Chicago
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Moline
 Garneau, Stewart C MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Porubcin, Michael MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Spector, David MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas L. Constantinou Ph: 319-363-2690
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Ronald A Sapiente Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Michael W. Method Ph: 574-237-1328
 Elkhart General Hospital
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Michael W. Method Ph: 574-237-1328
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Michael W. Method Ph: 574-237-1328
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Michael W. Method Ph: 574-237-1328
 Saint Joseph's Medical Center
 Michael W. Method Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Michael W. Method Ph: 574-237-1328
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
  South Bend
 CCOP - Northern Indiana CR Consortium
 Michael W. Method Ph: 574-237-1328
 Memorial Hospital of South Bend
 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
Iowa
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
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
  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
  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
 CCOP - 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
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Jyotsna Fuloria Ph: 888-562-4763
Maryland
  Elkton MD
 Union Hospital of Cecil County
 Stephen Scott Grubbs Ph: 302-733-6227
Massachusetts
  Boston
 Boston University Cancer Research Center
 Ariel E Hirsch Ph: 617-638-8265
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-3456
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Michael W. Method Ph: 574-237-1328
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Michael W. Method Ph: 574-237-1328
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Brainerd
 St. Joseph's Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Burnsville
 Fairview Ridges Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Duluth
 CCOP - Duluth
 Daniel Nikcevich Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Daniel Nikcevich Ph: 888-203-7267
 Miller - Dwan Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Edina
 Fairview Southdale Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Mankato
 Immanuel St. Joseph's
 Mohmmad J Ranginwala Ph: 507-385-2929
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Robert C. Miller Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Robert L Carolla Ph: 417-269-4520
  Cape Girardeau
 Southeast Cancer Center
 Bryan A Faller Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Bryan A Faller Ph: 800-392-0936
  Saint Louis
 Missouri Baptist Cancer Center
 Bryan A Faller Ph: 800-392-0936
  Springfield
 Cancer Research for the Ozarks
 Robert L Carolla Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert L Carolla Ph: 417-269-4520
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
 Hematology-Oncology Centers of the Northern Rockies - Billings
 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
 Montana Cancer Specialists at Montana Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 800-253-4368
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 800-253-4368
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 800-253-4368
 Creighton University Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Immanuel Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Lakeside Hospital
 Gamini S. Soori Ph: 800-253-4368
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Douglas Jay Weckstein Ph: 603-224-2556
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Douglas Jay Weckstein Ph: 603-224-2556
  Laconia
 Lakes Region General Hospital
 Douglas Jay Weckstein Ph: 603-224-2556
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Stephen Scott Grubbs Ph: 302-733-6227
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Benny J. Liem Ph: 505-272-6972
  Las Cruces
 Memorial Medical Center
 Benny J. Liem Ph: 505-272-6972
New York
  Mount Kisco
 Northern Westchester Hospital
 Alfred Tinger Ph: 888-823-5923
  Email: ctsucontact@westat.com
North Carolina
  Asheboro
 Randolph Hospital
 Peter Rubin Ph: 336-832-0821
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Gastonia
 CaroMont Cancer Center at Gaston Memorial Hospital
 Charles J. Meakin Ph: 704-834-2932
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Peter Rubin Ph: 336-832-0821
  Hendersonville
 Park Ridge Hospital Breast Health Center
 Patricia C Griffin Ph: 800-486-5941
  High Point
 High Point Regional Hospital
 Kulbir Kolby Sidhu Ph: 336-878-6107
  Reidsville
 Annie Penn Cancer Center
 Peter Rubin Ph: 336-832-0821
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 Mid Dakota Clinic, PC
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 St. Alexius Medical Center Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
  Fargo
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Grant R Seeger Ph: 701-780-6520
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 502-361-8496
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Evan J Wuthrick Ph: 866-627-7616
  Email: osu@emergingmed.com
 CCOP - Columbus
 J. Philip Kuebler Ph: 502-361-8496
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 502-361-8496
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 502-361-8496
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 502-361-8496
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 502-361-8496
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 317-783-8918
 Good Samaritan Hospital
 Howard M. Gross Ph: 317-783-8918
 Grandview Hospital
 Howard M. Gross Ph: 317-783-8918
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 317-783-8918
  Delaware
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Elyria
 Hematology Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Mercy Cancer Center - Elyria
 Rex B Mowat Ph: 517-265-0116
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 502-361-8496
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 502-361-8496
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 502-361-8496
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 502-361-8496
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 502-361-8496
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 Toledo Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 502-361-8496
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 502-361-8496
Oregon
  Glesham
 Legacy Mount Hood Medical Center
 Regan M Look Ph: 503-413-1742
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Regan M Look Ph: 503-413-1742
  Tualatin
 Legacy Meridian Park Hospital
 Regan M Look Ph: 503-413-1742
South Carolina
  Anderson
 AnMed Cancer Center
 Patricia C Griffin Ph: 800-486-5941
  Greenville
 Bon Secours St. Francis Health System
 Patricia C Griffin Ph: 800-486-5941
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
 Greenville Memorial Hospital
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
 CCOP - Upstate Carolina
 Patricia C Griffin Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Asheesh Shipstone Ph: 423-578-8538
Virginia
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
Washington
  Vancouver
 Legacy Salmon Creek Medical Center
 Regan M Look Ph: 503-413-1742
West Virginia
  Huntington
 Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
 Maria-Rosalia B. Tria Tirona Ph: 304-399-6617
Wisconsin
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Matthias Weiss Ph: 800-347-0673
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Matthias Weiss Ph: 800-347-0673
  Fond Du Lac
 Central Wisconsin Cancer Program at Agnesian HealthCare
 Timothy P Korytko Ph: 800-494-2927
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Anthony J. Jaslowski Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Anthony J. Jaslowski Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Anthony J. Jaslowski Ph: 800-432-6049
  Marshfield
 Marshfield Clinic - Marshfield Center
 Matthias Weiss Ph: 800-347-0673
 Saint Joseph's Hospital
 Matthias Weiss Ph: 800-347-0673
  Minocqua
 Marshfield Clinic - Lakeland Center
 Matthias Weiss Ph: 800-347-0673
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Matthias Weiss Ph: 800-347-0673
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Matthias Weiss Ph: 800-347-0673
  Sheboygan
 Saint Nicholas Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Matthias Weiss Ph: 800-347-0673
 Saint Michael's Hospital Cancer Center
 Matthias Weiss Ph: 800-347-0673
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
  Weston
 Marshfield Clinic - Weston Center
 Matthias Weiss Ph: 800-347-0673
 Ministry Saint Clare's Hospital
 Matthias Weiss Ph: 800-347-0673

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01198145
Information obtained from ClinicalTrials.gov on February 21, 2013

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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