Endometrial Cancer
Conditions
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial papillary serous carcinoma, endometrial clear cell carcinoma
Brief 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.
Detailed description
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.
Interventions
DRUGcisplatin
DRUGdoxorubicin hydrochloride
DRUGepirubicin hydrochloride
PROCEDUREadjuvant therapy
PROCEDUREconventional surgery
RADIATIONradiation therapy
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Countries
Belgium, France, Ireland, Italy, Netherlands, Norway, Poland, Portugal, South Africa, Spain, United Kingdom
Outcome results
None listed