Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT00005583|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: cisplatin Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma|
|Study Start Date :||January 2000|
|Actual Study Completion Date :||July 2010|
- Progression-free survival
- Relapse-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005583
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Cazk Groeninghe - Campus Maria's Voorzienigheid|
|Kortrijk, Belgium, B-8500|
|Leuven, Belgium, B-3000|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Coombe Women's Hospital|
|Dublin, Ireland, 8|
|St. James's Hospital|
|Dublin, Ireland, 8|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Naples, Italy, 80131|
|Azienda Ospedaliera Di Parma|
|Parma, Italy, 43100|
|Fondazione I.R.C.C.S. Policlinico San Matteo|
|Pavia, Italy, 27100|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Medisch Spectrum Twente|
|Enschede, Netherlands, 7500 KA|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|Hospitais da Universidade de Coimbra (HUC)|
|Coimbra, Portugal, 3049|
|Groote Schuur Hospital|
|Cape Town, South Africa, 7925|
|Hospital Universitario San Carlos|
|Madrid, Spain, 28040|
|Hospital Universitario Central de Asturias|
|Oviedo, Spain, 33006|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Centre for Cancer Research and Cell Biology at Belfast City Hospital|
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Gunnar B. Kristensen, MD, PhD||Norwegian Radium Hospital|
|OverallOfficial:||Carlos F. de Oliveira, MD, PhD||Hospitais da Universidade de Coimbra (HUC)|