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Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Primary Purpose

Desmoid Tumor

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Desmoid Tumor focused on measuring desmoid tumor

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • Institut Bergonie
  • Centre Leon Berard
  • CHU de la Timone
  • Southwest German Cancer Center at Eberhard-Karls-University
  • Arnhems Radiotherapeutisch Instituut
  • University Medical Center Groningen
  • Leiden University Medical Center
  • Maastro Clinic - Locatie Maastricht
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Dr. Bernard Verbeeten Instituut
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Centre Hospitalier Universitaire Vaudois
  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
  • Cookridge Hospital
  • Christie Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital NHS Trust
  • Cancer Research Centre at Weston Park Hospital
  • Royal Marsden - Surrey

Outcomes

Primary Outcome Measures

Local control as assessed by MRI at 3 years

Secondary Outcome Measures

Toxicity as assessed by CTC 2.0
Response as assessed by MRI

Full Information

First Posted
February 14, 2002
Last Updated
August 26, 2013
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00030680
Brief Title
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Official Title
Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desmoid Tumor
Keywords
desmoid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Local control as assessed by MRI at 3 years
Secondary Outcome Measure Information:
Title
Toxicity as assessed by CTC 2.0
Title
Response as assessed by MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. B. Keus, MD
Organizational Affiliation
Arnhems Radiotherapeutisch Instituut
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Schnabel, MD
Organizational Affiliation
Klinikum der Stadt Ludwigshafen am Rhein
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Arnhems Radiotherapeutisch Instituut
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Maastro Clinic - Locatie Maastricht
City
Maastricht
ZIP/Postal Code
NL-6229 ET
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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Radiation Therapy in Treating Patients With Aggressive Fibromatoses

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