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Tracking Information | |||||||||
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First Received Date † | February 14, 2002 | ||||||||
Last Updated Date | February 6, 2009 | ||||||||
Start Date † | November 2001 | ||||||||
Current Primary Outcome Measures † |
Local control as assessed by MRI at 3 years [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00030680 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | Radiation Therapy in Treating Patients With Aggressive Fibromatoses | ||||||||
Official Title † | Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses | ||||||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment | ||||||||
Condition † | Desmoid Tumor | ||||||||
Intervention † | Radiation: radiation therapy | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 40 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Gender | Both | ||||||||
Ages | 16 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | Belgium, France, Germany, Netherlands, Poland, Switzerland, United Kingdom | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00030680 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | EORTC-62991, EORTC-22998 | ||||||||
Study Sponsor † | European Organization for Research and Treatment of Cancer | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | April 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |