Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

• Status: Completed
• Trial end date: 2010-07-01
• 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 with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.

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

Details

• Lead Sponsor: Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Collaborator: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Doxorubicin; Epirubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed endometrial cancer of 1 of the following types:

• Clear cell carcinoma

• Serous papillary carcinoma

• Undifferentiated (anaplastic) carcinoma

• Poorly differentiated (FIGO grade 3) adenocarcinoma with infiltration to more than half the myometrial thickness

• No small cell carcinoma with neuroendocrine differentiation

• Primary in FIGO surgical stage I or occult stage II

• No spread of disease outside the uterine corpus except to pelvic lymph nodes

• No spread of disease to para-aortic lymph nodes

• Positive peritoneal washings allowed

• No preoperative macroscopic tumor involvement of the cervix

• Microscopic tumor involvement of the cervix on histopathological evaluation of the operative uterine specimen allowed

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Adequate bone marrow function

• WBC at least 3,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Adequate hepatic function

Renal:

• Adequate renal function

• Creatinine no greater than 1.4 mg/dL

Pulmonary:

• Adequate pulmonary function

Other:

• Not pregnant or nursing

• Fit to receive combination chemotherapy

• No other malignancy except basal cell or squamous cell skin cancer

• No uncontrolled or potentially active site of infection (e.g., fistula or abscesses)

• No other concurrent condition that would produce a substantial increase in risk for complications from radiotherapy

• No other concurrent condition that would interfere with adequate follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior preoperative irradiation

Surgery:

• No prior extensive abdominal surgery