Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Desmoid Tumor Clinical Trial

Official title:

Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030680
• Other study ID #: EORTC-62991-22998
• Secondary ID: EORTC-62991EORTC
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: August 26, 2013
• Start date: November 2001
• Est. completion date: March 2012

Study information

• Verified date: August 2013
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Desmoid Tumor

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
France	Institut Bergonie	Bordeaux
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
Germany	Southwest German Cancer Center at Eberhard-Karls-University	Tuebingen
Netherlands	Arnhems Radiotherapeutisch Instituut	Arnhem
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastro Clinic - Locatie Maastricht	Maastricht
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Poland,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control as assessed by MRI at 3 years			No
Secondary	Toxicity as assessed by CTC 2.0			Yes
Secondary	Response as assessed by MRI			No