NCT Number: NCT00030680
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Cliniques Universitaires Saint-Luc, Brussels, Belgium
About this study
OBJECTIVES:
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive fibromatoses arising in any site
- Primary, recurrent, or progressive disease that is inoperable or requires a major operation resulting in a large functional or cosmetic deficit or mutilation
- Progressive disease defined as at least 20% increase in tumor size on 2 MRI scans within 1 year after any prior therapy except radiotherapy OR
- Incompletely resected tumor with gross residual disease not suitable for further surgery
- Resected within the past 3 months
- Lesions must be suitable for radiotherapy
- No bulky intra-abdominal disease in close relation to small bowel
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No conditions that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed
- No concurrent chemotherapy
Endocrine therapy:
- Prior endocrine therapy allowed
- No concurrent endocrine therapy
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to indicator lesion
Surgery:
- See Disease Characteristics
- Prior surgery allowed
Other:
- No prior isolated limb perfusion with tumor necrosis factor
- No concurrent isolated limb perfusion with tumor necrosis factor
Treatment and study plan
Primary outcomes
-
Local control as assessed by MRI at 3 years
Secondary outcomes
-
Toxicity as assessed by CTC 2.0
-
Response as assessed by MRI
Sponsors and collaborators
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Network
Registry information
Official study title
Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Important dates
- Study start
- 2001
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jan 27, 2003
- Registry last updated
- Aug 27, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Burden of Disease and Living Situation in Desmoid Patients
NCT06258421
Desmoid Tumor, Desmoid Tumors
Dresden, Saxony, Germany
View Trial DetailsNivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers
NCT03190174
Adenocarcinoma, Bronchial Neoplasms
Santa Monica, California, United States
View Trial DetailsNirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
NCT03785964
Aggressive Fibromatosis, Desmoid Tumor
Little Rock, Arkansas, United States
View Trial DetailsMR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors
NCT02076906
Adenocarcinoma, Carcinoma
Washington D.C., District of Columbia, United States
View Trial Details