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Radiation Therapy in Treating Patients With Aggressive Fibromatoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030680
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2013
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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
Desmoid Tumor Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Primary Purpose: Treatment
Official Title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Study Start Date : November 2001
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 16 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No conditions that would preclude study follow-up


Biologic therapy:

  • Not specified


  • Prior chemotherapy allowed
  • No concurrent chemotherapy

Endocrine therapy:

  • Prior endocrine therapy allowed
  • No concurrent endocrine therapy


  • See Disease Characteristics
  • No prior radiotherapy to indicator lesion


  • See Disease Characteristics
  • Prior surgery allowed


  • No prior isolated limb perfusion with tumor necrosis factor
  • No concurrent isolated limb perfusion with tumor necrosis factor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030680

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Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Institut Bergonie
Bordeaux, France, 33076
Centre Leon Berard
Lyon, France, 69008
CHU de la Timone
Marseille, France, 13385
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
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
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: R. B. Keus, MD Arnhems Radiotherapeutisch Instituut
Study Chair: Thomas Schnabel, MD Klinikum der Stadt Ludwigshafen am Rhein

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00030680     History of Changes
Other Study ID Numbers: EORTC-62991-22998
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
desmoid tumor
Additional relevant MeSH terms:
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Fibromatosis, Aggressive
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type