Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Desmoid Tumor |
Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2001 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Leon Berard | |
| Lyon, France, 69008 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Germany | |
| Southwest German Cancer Center at Eberhard-Karls-University | |
| Tuebingen, Germany, D-72076 | |
| Netherlands | |
| 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 | |
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | |
| Birmingham, England, United Kingdom, B15 2TH | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Christie Hospital | |
| 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 | |
| Investigator: | R. B. Keus, MD | Arnhems Radiotherapeutisch Instituut |
| Investigator: | Thomas Schnabel, MD | Klinikum der Stadt Ludwigshafen am Rhein |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00030680 History of Changes |
| Other Study ID Numbers: | CDR0000069188, EORTC-62991, EORTC-22998 |
| Study First Received: | February 14, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
desmoid tumor |
Additional relevant MeSH terms:
|
Fibroma Fibromatosis, Aggressive Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013