Radiation Therapy in Treating Patients With Aggressive Fibromatoses
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|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|
|Actual Primary Completion Date :||March 2012|
|Actual 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
|Study Chair:||R. B. Keus, MD||Arnhems Radiotherapeutisch Instituut|
|Study Chair:||Thomas Schnabel, MD||Klinikum der Stadt Ludwigshafen am Rhein|