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

Trial Status: Active

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.

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 205-934-0220
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
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Peoria
Arizona Center for Cancer Care-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 623-773-2873
Phoenix
Saint Joseph's Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-602-4111
University of Arizona Cancer Center at Saint Joseph's
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 602-406-8222
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

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 818-847-4793
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Carmichael
Mercy San Juan Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-556-3301
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-822-5354
Modesto
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
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
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
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: 415-209-2686
Saint Helena
Saint Helena Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 707-967-3698

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Englewood
Swedish Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663

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

District of Columbia

Washington
Sibley Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 202-243-2373

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: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-243-2647
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 954-265-1847
Email: OHR@mhs.net
Kissimmee
AdventHealth Kissimmee
Status: ACTIVE
Contact: Site Public Contact
Phone: 407-846-4343
Miami
Jackson Memorial Hospital-Holtz Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-243-3975
Miami Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 786-596-2000
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
AdventHealth Orlando
Status: ACTIVE
Contact: Site Public Contact
Phone: 407-303-2090

Georgia

Atlanta
Grady Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-489-9164
Northside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-303-3355
Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-721-2388
Decatur
Dekalb Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-501-2738
Gainesville
Northeast Georgia Medical Center-Gainesville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 770-219-8800
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Memorial Health University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-350-7887

Hawaii

Honolulu
Queen's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-545-8548
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
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-942-5498
Decatur
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
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
OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605

Indiana

Anderson
Saint Vincent Anderson Regional Hospital / Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-338-2194
Beech Grove
Franciscan Saint Francis Health-Beech Grove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-783-8918
Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 260-373-8888
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
Franciscan Health Indianapolis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-528-7060
Saint Vincent Hospital and Health Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-338-2194
Mishawaka
Michiana Hematology Oncology PC-Mishawaka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-237-1328
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
Mason City
Mercy Medical Center - North Iowa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-433-3883

Kansas

Kansas City
University of Kansas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Overland Park
University of Kansas Cancer Center-Overland Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-362-0070
Wesley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Louisiana

New Orleans
University Medical Center New Orleans
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

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
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
Silver Spring
Holy Cross Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 310-754-7552

Michigan

Adrian
Hickman Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 517-265-0116
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Kalamazoo
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Port Huron
Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Warren
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Minneapolis
Abbott-Northwestern Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Rochester
Mayo Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Kansas City
The University of Kansas Cancer Center-North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
The University of Kansas Cancer Center-South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
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

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
Morristown
Morristown Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 973-971-5900
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
Red Bank
Riverview Medical Center / Booker Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-530-2382
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
Southwest Gynecologic Oncology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Brooklyn
State University of New York Downstate Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-613-8324
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592
Mount Sinai Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
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: WITHDRAWN
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Fargo
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Akron
Cleveland Clinic Akron General
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Summa Health System - Akron Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Barberton
Summa Health System - Barberton Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: WITHDRAWN
Contact: Site Public Contact
Phone: 800-641-2422
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: COMPLETED
Contact: Site Public Contact
Phone: 800-641-2422
Columbus
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Medina
Summa Health Medina Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 330-375-4221
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Ravenna
University Hospitals Portage Medical Center
Status: WITHDRAWN
Contact: Site Public Contact
Phone: 800-641-2422
Salem
UH Seidman Cancer Center at Salem Regional Medical Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Site Public Contact
Phone: 800-641-2422
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: WITHDRAWN
Contact: Site Public Contact
Phone: 800-641-2422
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
University of Toledo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-383-6583
Westlake
UHHS-Westlake Medical Center
Status: WITHDRAWN
Contact: Site Public Contact
Phone: 800-641-2422
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
Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 918-494-2200

Oregon

Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Drexel Hill
Delaware County Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 610-284-8237
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-728-4790
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
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-481-2402
Wynnewood
Lankenau Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-476-2649

Rhode Island

Providence
Women and Infants Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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
Greenville
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066

South Dakota

Rapid City
Rapid City Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-716-3982
Sioux Falls
Avera Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-634-7268
Sanford Cancer Center Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Kingsport
Wellmont Holston Valley Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
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
Houston
Ben Taub General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-873-2000
Houston Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-790-2700
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

Utah

Cedar City
Sandra L Maxwell Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-868-5680
Logan
Logan Regional Hospital
Status: ACTIVE
Contact: Anuja Jhingran
Murray
Intermountain Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-387-7426
Saint George
Dixie Medical Center Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100
South Jordan
South Jordan Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100

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
Tacoma
MultiCare Tacoma General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-3229
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 509-574-3535

West Virginia

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Milwaukee
Aurora Saint Luke's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-805-3666
West Allis
Aurora West Allis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304

Quebec

Montreal
McGill University Department of Oncology
Status: ACTIVE
Contact: Luis Souhami
Phone: 514-934-1934extn42953
The Research Institute of the McGill University Health Centre (MUHC)
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-934-1934ext48354

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: TEMPORARILY_CLOSED_TO_ACCRUAL
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: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
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: ACTIVE
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

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 Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Anuja Jhingran

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