Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer

OBJECTIVES:

• Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy.
• Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

• Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a week for 5.5 weeks.
• Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following:

• Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)
• Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)
• No grade I adenocarcinoma
• Less than 50% papillary serous or clear cell histology on pathologic specimen
• Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study
• No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,800/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No cardiac dysrhythmias

Other:

• No other malignancy within the past 5 years except nonmelanomatous skin cancer
• No medical contraindications to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics