Know Cancer

forgot password


Phase 3
Not Enrolling
Endometrial Cancer, Psychosocial Effects of Cancer and Its Treatment

Thank you

Trial Information


OBJECTIVES: I. Compare overall survival, progression-free interval, and patterns of failure
of maximally debulked patients with stage III/IV endometrial carcinoma treated with
whole-abdominal irradiation vs. doxorubicin/cisplatin. II. Compare the incidence and type of
acute and late adverse events observed with these two treatment regimens. III. Compare
changes in fatigue, elimination, and neurologic impairment that impact on quality of life in
patients treated with these two regimens. IV. Assess the difference in short-term versus
long-term impact on quality of life between the two treatment groups. V. Compare
quality-of-life outcomes over time between these two treatment groups.

OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-abdominal irradiation using equipment
with photon energies ranging from 6 to 25 MV. Arm II: 2-Drug Combination Chemotherapy.
Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: It is anticipated that 355 patients will be entered over 7.4 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Pathological stage III/IV endometrial carcinoma of any histology
(including clear cell and serous papillary carcinomas) The following extent of disease
eligible: Positive adnexa Tumor invading the serosa Positive pelvic nodes Positive
para-aortic nodes Involvement of the bowel mucosa Intra-abdominal metastases Positive
pelvic washings Vaginal involvement within the radiotherapy field Hysterectomy and
bilateral salpingo-oophorectomy (BSO) required with residual tumor not greater than 2 cm
at any site Selective pelvic and para-aortic lymph node sampling optional for patients
with stage III/IV disease by other criteria If para-aortic nodes are positive, scalene
nodes must be negative on biopsy and chest CT must be negative for intrathoracic disease
The following disease conditions exclude: Parenchymal liver metastasis Lung metastasis
Positive inguinal nodes Positive scalene nodes Recurrent disease Protocol therapy must
begin within 8 weeks after surgery

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Hematopoietic: WBC
at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3
times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular
ejection fraction normal Other: No past or concomitant malignancy other than
nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Prior progestational agents allowed No other prior
endocrine therapy Radiotherapy: No prior pelvic or abdominal radiotherapy Surgery:
Hysterectomy and BSO required Pelvic and para-aortic lymph node sampling optional (see
Disease Characteristics)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Marcus E. Randall, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 1992

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial adenoacanthoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • psychosocial effects of cancer and its treatment
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
Stanford University Medical Center Stanford, California  94305-5408
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
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
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
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
Brookview Research, Inc. Winston-Salem, North Carolina  27103
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117