Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also make tumor cells more sensitive to cisplatin. Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Cisplatin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of endometrial cancer, including any of the following cellular types:

• Papillary serous carcinoma

• Clear cell carcinoma

• Adenocarcinoma

• Stage III or IV disease

• No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes)

• Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks

• Peritoneal washings must have been collected for cytological evaluation

• Must have ≤ 1 cm residual disease after surgery

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Life expectancy ≥ 6 months

• WBC ≥ 3,000/mm^3

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Creatinine < 2.0 mg/dL

• Bilirubin < 1.5 times upper limit of normal (ULN)

• Lactate dehydrogenase < 3 times ULN

• Gamma glutamyl transferase < 3 times ULN

• SGPT and SGOT < 3 times ULN

• Alkaline phosphatase < 3 times ULN

• No other malignant tumor within the past 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior radiotherapy to the whole abdomen and/or pelvis/vagina

• No systemic chemotherapy within the past 5 years