Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
NCT ID: NCT00002459
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
1988-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
FEMALE
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Sergio L. Pecorelli, MD
Role: STUDY_CHAIR
Spedali Civili di Brescia
Gavin C.E. Stuart, MD
Role: STUDY_CHAIR
Tom Baker Cancer Centre - Calgary
Locations
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U.Z. Gasthuisberg
Leuven, , Belgium
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Centre Henri Becquerel
Rouen, , France
Spedali Civili
Brescia, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, , Italy
Istituto Scientifico H.S. Raffaele
Milan, , Italy
Ospedale San Gerardo
Monza, , Italy
Universita di Padova
Padua, , Italy
I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale Civile
Voghera (PV), , Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Atrium Medical Centre
Heerlen, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , Netherlands
Rotterdam Cancer Institute
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Instituto Valenciano De Oncologia
Valencia, , Spain
University Hospital of Linkoping
Linköping, , Sweden
Karolinska Hospital
Stockholm, , Sweden
Hopital Cantonal Universitaire de Geneva
Geneva, , Switzerland
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2.
Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.
Other Identifiers
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EORTC-55874
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-EN4
Identifier Type: -
Identifier Source: secondary_id
EORTC-55874
Identifier Type: -
Identifier Source: org_study_id