Radiation Therapy in Treating Patients With Aggressive Fibromatoses
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses|
- Local control as assessed by MRI at 3 years [ Designated as safety issue: No ]
- Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
- Response as assessed by MRI [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
- Determine the efficacy of moderate-dose radiotherapy, in terms of local control, in patients with aggressive fibromatoses.
- Determine the acute and late side-effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive radiotherapy 5 days a week for 5.5 weeks for a total of 56 Gy in 28 fractions.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030680
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Bordeaux, France, 33076|
|Centre Leon Berard|
|Lyon, France, 69008|
|CHU de la Timone|
|Marseille, France, 13385|
|Southwest German Cancer Center at Eberhard-Karls-University|
|Tuebingen, Germany, D-72076|
|Arnhems Radiotherapeutisch Instituut|
|Arnhem, Netherlands, 6815 AD|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Maastro Clinic - Locatie Maastricht|
|Maastricht, Netherlands, NL-6229 ET|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Dr. Bernard Verbeeten Instituut|
|Tilburg, Netherlands, 5042 SB|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Warsaw, Poland, 02-781|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2TH|
|Leeds, England, United Kingdom, LS16 6QB|
|Manchester, England, United Kingdom, M20 4BX|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||R. B. Keus, MD||Arnhems Radiotherapeutisch Instituut|
|Study Chair:||Thomas Schnabel, MD||Klinikum der Stadt Ludwigshafen am Rhein|