Radiation Therapy in Treating Patients With Aggressive Fibromatoses

August 26, 2013 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local control as assessed by MRI at 3 years

Secondary Outcome Measures

Outcome Measure
Toxicity as assessed by CTC 2.0
Response as assessed by MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 26, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-62991-22998
  • EORTC-62991
  • EORTC-22998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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