Endometrial Cancer Clinical Trial
Official title:
WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III
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. It is not yet known which treatment regimen is more effective for endometrial cancer.
PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in
treating patients who have advanced endometrial cancer.
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.
;
Primary Purpose: Treatment
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