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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially. Compare overall survival of this patient population treated with these 2 adjuvant regimens. Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients. Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and histologic type (serous papillary and clear cell vs all other types). Patients are randomized to 1 of 2 treatment arms. All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes. Arm I: Within 7 weeks after surgery, patients begin radiotherapy. Arm II: Patients receive radiotherapy followed by or preceded by chemotherapy*. Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1. Treament repeats every 21 days for 4 courses. NOTE: *If radiotherapy is preceded by chemotherapy, radiotherapy begins within 4 weeks after chemotherapy. Patients are followed at 3 and 6 months and then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.

Official Title
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A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: doxorubicin hydrochloride
* Drug: epirubicin hydrochloride
* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: epirubicin hydrochloride|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: conventional surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Relapse-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial papillary serous carcinoma, endometrial clear cell carcinoma