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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


Phase 3
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard D. Homesley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Network

Authority:

United States: Federal Government

Study ID:

CDR0000068020

NCT ID:

NCT00006011

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial adenoacanthoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Evanston Evanston, Illinois  60201
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology Associates Knoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Cooper University Hospital Camden, New Jersey  08103
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tufts - New England Medical Center Boston, Massachusetts  02111
Fletcher Allen Health Care - Medical Center Campus Burlington, Vermont  05401
Arthur G. James Cancer Hospital at Ohio State University Columbus, Ohio  43210-1240
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
Gynecologic Oncology Network Nashville, Tennessee  37203
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259
Siteman Cancer Center Saint Louis, Missouri  63110
Abramson Cancer Center of the University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104-4283
Women's Cancer Center at Community Hospital of Los Gatos Los Gatos, California  95032
Multicare Medical Center Tacoma, Washington  98405