NCT00005583

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	doxorubicin hydrochloride
DRUG	epirubicin hydrochloride
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 2000-01-01
• Completion: 2010-07-01
• First posted: 2003-01-27
• Last updated: 2013-08-02

Locations

23 sites across 11 countries: Belgium, France, Ireland, Italy, Netherlands, Norway, Poland, Portugal, South Africa, Spain, United Kingdom