Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
- Conditions
- Endometrial Cancer
- Registration Number
- NCT00005583
- Lead Sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival Relapse-free survival
- Secondary Outcome Measures
Name Time Method Overall survival
Trial Locations
- Locations (23)
Centre for Cancer Research and Cell Biology at Belfast City Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Azienda Ospedaliera Di Parma
🇮🇹Parma, Italy
Centre Henri Becquerel
🇫🇷Rouen, France
Coombe Women's Hospital
🇮🇪Dublin, Ireland
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Medical University of Gdansk
🇵🇱Gdansk, Poland
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
St. James's Hospital
🇮🇪Dublin, Ireland
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands