Radiation Therapy in Treating Patients With Aggressive Fibromatoses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00030680
First received: February 14, 2002
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Desmoid Tumor
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Local control as assessed by MRI at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
  • Response as assessed by MRI [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2001
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030680

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

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00030680     History of Changes
Other Study ID Numbers: EORTC-62991-22998, EORTC-62991, EORTC-22998
Study First Received: February 14, 2002
Last Updated: August 26, 2013
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
desmoid tumor

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on October 23, 2014