Radiation Therapy in Treating Patients With Aggressive Fibromatoses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00030680|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Desmoid Tumor||Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Official Title:||Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses|
|Study Start Date :||November 2001|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
- Local control as assessed by MRI at 3 years
- Toxicity as assessed by CTC 2.0
- Response as assessed by MRI
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): 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|