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Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00030680
Collaborator
(none)
44
Enrollment
21
Locations
124
Duration (Months)
2.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: radiation therapy
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Primary Purpose:
Treatment
Official Title:
Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Study Start Date :
Nov 1, 2001
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Outcome Measures

Primary Outcome Measures

  1. Local control as assessed by MRI at 3 years []

Secondary Outcome Measures

  1. Toxicity as assessed by CTC 2.0 []

  2. Response as assessed by MRI []

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
2 Universitair Ziekenhuis Antwerpen Edegem Belgium B-2650
3 Institut Bergonie Bordeaux France 33076
4 Centre Leon Berard Lyon France 69008
5 CHU de la Timone Marseille France 13385
6 Southwest German Cancer Center at Eberhard-Karls-University Tuebingen Germany D-72076
7 Arnhems Radiotherapeutisch Instituut Arnhem Netherlands 6815 AD
8 University Medical Center Groningen Groningen Netherlands 9700 RB
9 Leiden University Medical Center Leiden Netherlands 2300 RC
10 Maastro Clinic - Locatie Maastricht Maastricht Netherlands NL-6229 ET
11 Daniel Den Hoed Cancer Center at Erasmus Medical Center Rotterdam Netherlands 3008 AE
12 Dr. Bernard Verbeeten Instituut Tilburg Netherlands 5042 SB
13 Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Warsaw Poland 02-781
14 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland CH-1011
15 Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Birmingham England United Kingdom B15 2TH
16 Cookridge Hospital Leeds England United Kingdom LS16 6QB
17 Christie Hospital Manchester England United Kingdom M20 4BX
18 Mount Vernon Cancer Centre at Mount Vernon Hospital Northwood England United Kingdom HA6 2RN
19 Nottingham City Hospital NHS Trust Nottingham England United Kingdom NG5 1PB
20 Cancer Research Centre at Weston Park Hospital Sheffield England United Kingdom S1O 2SJ
21 Royal Marsden - Surrey Sutton England United Kingdom SM2 5PT

Sponsors and Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: R. B. Keus, MD, Arnhems Radiotherapeutisch Instituut
  • Study Chair: Thomas Schnabel, MD, Klinikum der Stadt Ludwigshafen am Rhein

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00030680
Other Study ID Numbers:
  • EORTC-62991-22998
  • EORTC-62991
  • EORTC-22998
First Posted:
Jan 27, 2003
Last Update Posted:
Aug 27, 2013
Last Verified:
Aug 1, 2013
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
desmoid tumor
Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma

Study Results

No Results Posted as of Aug 27, 2013