A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
- Compare relapse-free survival of patients with high-risk endometrial carcinoma treated
in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy
- Compare overall survival of this patient population treated with these 2 adjuvant
- 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
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Gunnar B. Kristensen, MD, PhD
Norwegian Radium Hospital
United States: Federal Government