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Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006011
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2000
Detailed Description:

OBJECTIVES:

  • Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel.
  • Compare short and long-term toxic effects of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field).

Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery.

Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.

  • Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or pegfilgrastim on days 2-11.
  • Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12.

Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced endometrial carcinoma with any histology, including:

    • Clear cell and serous papillary carcinoma
  • Surgical stage III disease, including:

    • Positive adnexa
    • Tumor invading the serosa
    • Positive pelvic and/or paraaortic nodes
    • Involvement of bowel mucosa
    • Intraabdominal metastases
    • Positive pelvic washings
    • Vaginal involvement within the radiation port
  • Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy

    • Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm
    • Paraaortic lymph node sampling allowed

      • If positive, must have negative chest CT scan
  • No recurrent disease
  • No parenchymal liver metastases
  • No disease outside the abdomen

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT/SGPT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal

Renal:

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular:

  • LVEF at least 50% within 6 months of study entry

Other:

  • No other prior or concurrent malignancy within the past 5 years except adequately treated nonmelanoma skin cancer
  • No serious comorbid illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for prior malignancy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006011

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1740
Women's Cancer Center at Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62794-9640
CCOP - Evanston
Evanston, Illinois, United States, 60201
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612-3824
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01605-2982
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Cooper University Hospital
Camden, New Jersey, United States, 08103-1489
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, New York
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11790-7775
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States, 43210-1240
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, Tennessee
Gynecologic Oncology Network
Nashville, Tennessee, United States, 37203
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States, 37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2516
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Multicare Medical Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
Gynecologic Oncology Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: Howard D. Homesley, MD Gynecologic Oncology Network
Study Chair: Higinia R. Cardenes, MD, PhD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068020, GOG-0184, ECOG-G0184, RTOG-EN0130
Study First Received: July 5, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006011     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial adenoacanthoma
endometrial papillary carcinoma
endometrial clear cell carcinoma

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Uterine Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009