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Brief Title: Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
Official Title: A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
Study ID: NCT00005583
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid, Kortrijk, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Centre Henri Becquerel, Rouen, , France
Coombe Women's Hospital, Dublin, , Ireland
St. James's Hospital, Dublin, , Ireland
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , Italy
Azienda Ospedaliera Di Parma, Parma, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
Medical University of Gdansk, Gdansk, , Poland
Hospitais da Universidade de Coimbra (HUC), Coimbra, , Portugal
Groote Schuur Hospital, Cape Town, , South Africa
Hospital Universitario San Carlos, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Centre for Cancer Research and Cell Biology at Belfast City Hospital, Belfast, Northern Ireland, United Kingdom
Western Infirmary, Glasgow, Scotland, United Kingdom
Name: Gunnar B. Kristensen, MD, PhD
Affiliation: Norwegian Radium Hospital
Role: STUDY_CHAIR
Name: Carlos F. de Oliveira, MD, PhD
Affiliation: Hospitais da Universidade de Coimbra (HUC)
Role: