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

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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



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