Chemotherapy and Pelvic Radiation Therapy with or without Additional Chemotherapy in Treating Patients with High-Risk Early-Stage Cervical Cancer after Radical Hysterectomy

Status: Active

Description

This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy. Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry (NOTE: if the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a positron emission tomography [PET]-computed tomography [CT] is recommended, but not required; a negative pre or post-operative PET scan or PET-CT scan of the para–aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection)
  • Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery: * Positive pelvic nodes * Positive parametrium * Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)
  • No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible): * History/physical examination within 56 days prior to study entry * Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within 90 days prior to registration (NOTE: whole body PET-CT is preferred) * Chest x-ray (posterioranterior [PA] and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT)
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)
  • White blood cell count >= 4000 cells/mm^3
  • Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry
  • Bilirubin =< 1.5 times normal 14 days prior to study entry
  • Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry
  • Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and/or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) within upper limits of institutional normal within 14 days prior to study entry
  • Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol)
  • Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Patients can not have any neuroendocrine histology in pathology
  • Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry * Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol
  • Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin
  • Patients who have gross residual disease or distant metastatic disease

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu
Mobile
Providence Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 251-633-1890

Alaska

Anchorage
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Peoria
Arizona Center for Cancer Care-Peoria
Status: Active
Contact: Site Public Contact
Phone: 623-773-2873
Scottsdale
Arizona Breast Cancer Specialists-Scottsdale
Status: Active
Contact: Site Public Contact
Phone: 480-922-4600
Surprise
Arizona Center for Cancer Care-Surprise
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 818-847-4793
Email: Najee.Boucher@providence.org
Carmichael
Mercy San Juan Medical Center
Status: Active
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Modesto
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Orange
Saint Joseph Hospital - Orange
Status: Active
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Pomona
Pomona Valley Hospital Medical Center
Status: Active
Contact: Site Public Contact
Phone: 909-865-9555
Sacramento
Mercy Cancer Center - Sacramento
Status: Active
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org
Mercy General Hospital Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-453-4528
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 916-454-6500
Email: cancerinfo@sutterhealth.org
Saint Helena
Saint Helena Hospital
Status: Active
Contact: Site Public Contact
Phone: 707-967-3698

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Englewood
Swedish Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Loveland
McKee Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

Hartford
Hartford Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 860-545-5363
New Britain
The Hospital of Central Connecticut
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 860-224-5660

Florida

Atlantis
John Fitzgerald Kennedy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 561-964-2662
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Kissimmee
AdventHealth Kissimmee
Status: Active
Contact: Site Public Contact
Phone: 407-846-4343
Miami
Jackson Memorial Hospital-Holtz Children's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Miami Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-599-2456
Email: cancerinfo@baptisthealth.net
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Florida Hospital Orlando
Status: Active
Contact: Site Public Contact
Phone: 407-303-2090
Email: FH.Cancer.Research@flhosp.org

Georgia

Augusta
Augusta University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 706-721-2388
Email: ga_cares@augusta.edu
Decatur
Dekalb Medical Center
Status: Active
Contact: Site Public Contact
Phone: 404-501-2738
Email: clinicaltrialsoncology@dekalbmedical.org
Gainesville
Northeast Georgia Medical Center-Gainesville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 770-219-8800
Email: cancerpatient.navigator@nghs.com
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Hawaii

Honolulu
Queen's Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
University of Hawaii Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 808-586-2979

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Illinois

Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Peoria
Methodist Medical Center of Illinois
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com

Indiana

Fort Wayne
Parkview Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-784-4673
Radiation Oncology Associates PC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-437-2408
Hammond
Franciscan Saint Margaret Health-Hammond Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 708-891-9305
Indianapolis
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org
South Bend
Northern Indiana Cancer Research Consortium
Status: Active
Contact: Anuja Jhingran

Iowa

Cedar Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 319-365-4673
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-237-1225

Louisiana

New Orleans
University Medical Center New Orleans
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu

Maryland

Baltimore
Greater Baltimore Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-849-3706
Sinai Hospital of Baltimore
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-601-6120
Email: pridgely@lifebridgehealth.org
University of Maryland / Greenebaum Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-888-8823
Columbia
Central Maryland Radiation Oncology in Howard County
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 443-546-1300

Michigan

Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lansing
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Port Huron
Lake Huron Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Warren
Saint John Macomb-Oakland Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Minneapolis
Abbott-Northwestern Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144
University of Nebraska Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

New Hampshire

Manchester
Elliot Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 603-663-1800

New Jersey

Camden
Cooper Hospital University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 856-325-6757
Mount Holly
Virtua Memorial
Status: Active
Contact: Site Public Contact
Phone: 609-914-6762
Newark
Rutgers New Jersey Medical School
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: Active
Contact: Site Public Contact
Phone: 856-325-6757
Virtua Voorhees
Status: Active
Contact: Site Public Contact
Phone: 856-247-7395

New Mexico

Albuquerque
Lovelace Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: AYost@nmcca.org
Southwest Gynecologic Oncology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: RDraper@nmcca.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Brooklyn
State University of New York Downstate Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-613-8324
Email: seema.chittalae@downstate.edu
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Mount Sinai Chelsea
Status: Active
Contact: Site Public Contact
Phone: 212-367-1729
Email: CCTO@mssm.edu
Rochester
Highland Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Akron
Summa Akron City Hospital / Cooper Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 330-375-6101
Barberton
Summa Barberton Hospital
Status: Active
Contact: Site Public Contact
Phone: 330-615-4132
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Columbus
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Medina
Summa Health Center at Lake Medina
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 330-375-4045
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Ravenna
University Hospitals Portage Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Salem
UH Seidman Cancer Center at Salem Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Westlake
UHHS-Westlake Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Wooster
Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 330-375-4221

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Drexel Hill
Delaware County Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-284-8237
Email: jolene.garney@crozer.org
Lewistown
Lewistown Hospital
Status: Active
Contact: Site Public Contact
Phone: 717-242-7703
Email: HemonCCTrials@geisinger.edu
Pittsburgh
West Penn Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-578-5000
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: Active
Contact: Site Public Contact
Phone: 215-481-2402

Rhode Island

Providence
Women and Infants Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-274-1122

South Carolina

Anderson
AnMed Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-512-4651
Email: rhonda.ballew@anmedhealth.org
Greenville
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greer
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org

Tennessee

Kingsport
Wellmont Holston Valley Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Knoxville
University of Tennessee - Knoxville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 865-544-9773

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
The Methodist Hospital System
Status: Active
Contact: Site Public Contact
Phone: 713-790-2700

Utah

Logan
Logan Regional Hospital
Status: Active
Contact: Anuja Jhingran
Murray
Intermountain Medical Center
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Ogden
McKay-Dee Hospital Center
Status: Active
Contact: Site Public Contact
Phone: 801-387-7426
Email: officeofresearch@imail.org
Saint George
Dixie Medical Center Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Virginia

Roanoke
Carilion Clinic Gynecological Oncology
Status: Active
Contact: Site Public Contact
Phone: 540-985-8510

Washington

Seattle
Seattle Cancer Care Alliance
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-574-3535
Email: Memorial-ClinicalTrials@yvmh.org

West Virginia

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Milwaukee
Aurora Saint Luke's Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
West Allis
Aurora West Allis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org

Quebec

Montreal
McGill University Department of Oncology
Status: Active
Contact: Luis Souhami
Phone: 514-934-1934extn42953
Email: evelyn.ortega@muhc.mcgill.ca
The Research Institute of the McGill University Health Centre (MUHC)
Status: Active
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Email: evelyn.ortega@muhc.mcgill.ca

Hong Kong

Chai Wan
Pamela Youde Nethersole Eastern Hospital
Status: Active
Contact: Site Public Contact
Phone: 011 852 2595 7920

Korea, Republic of

Jung-Ku
Keimyung University-Dongsan Medical Center
Status: Active
Contact: Site Public Contact
Email: ho@dsmc.or.kr
Seongnam City
Seoul National University Bundang Hospital
Status: Active
Contact: Site Public Contact
Phone: 82-2-2072-2890
Seoul
Asan Medical Center
Status: Active
Contact: Site Public Contact
Email: irbksh@amc.seoul.kr
Gangnam Severance Hospital
Status: Active
Contact: Site Public Contact
Phone: 82-2-2019-3600
Korea Cancer Center Hospital
Status: Active
Contact: Site Public Contact
Phone: 011-82-02-9702-114
Kyung Hee University Hospital at Gangdong
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 82-2-961-0554
Seoul National University Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 011-82-760-2384
Yonsei University Health System-Severance Hospital
Status: Active
Contact: Site Public Contact
Email: ihcc@yuhs.ac

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if adjuvant systemic chemotherapy following chemoradiation therapy will improve disease-free survival compared to chemoradiation therapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after a radical hysterectomy.

SECONDARY OBJECTIVES:

I. To evaluate adverse events.

II. To evaluate overall survival.

III. To evaluate quality of life.

IV. To evaluate chemotherapy-induced neuropathy.

V. To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy with respect to toxicity and local control.

VI. To collect fixed tissue to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.

VII. To collect blood to identify secreted factors from serum and plasma that may be associated with adverse events or outcome, and to identify single nucleotide polymorphisms (SNPs) in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin intravenously (IV) over 1 hour once weekly for 6 weeks.

NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.

ARM II: Patients receive chemoradiotherapy as in Arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

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

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Anuja Jhingran

Trial IDs

Primary ID RTOG 0724/GOG-0724
Secondary IDs RTOG-0724, NCI-2011-01973, CDR0000654709, GOG-0724
Clinicaltrials.gov ID NCT00980954