Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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 whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Cisplatin; Ifosfamide; Isophosphamide mustard

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)

• Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port

• Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study

• No greater than 1 cm residual disease

• Cervical sarcomas also allowed

• No metastasis beyond the abdominal cavity at diagnosis, including the following:

• Parenchymal liver metastasis

• Lung metastasis

• Positive inguinal lymph nodes

• Positive scalene nodes

• Radiographic or pathologic evidence of bone or brain metastasis

PATIENT CHARACTERISTICS:

Age:

• 21 and over

Performance status:

• GOG 0-2

Hematopoietic:

• WBC at least 3,000/mm3

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

• Albumin at least 3 g/dL

• No acute hepatitis

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 50 mL/min

Other:

• No septicemia

• No severe infection

• No severe gastrointestinal bleeding

• No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior hormonal therapy allowed

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No prior therapy that would preclude study therapy