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

February 14, 2002
August 26, 2013
November 2001
March 2012   (final data collection date for primary outcome measure)
Local control as assessed by MRI at 3 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00030680 on ClinicalTrials.gov Archive Site
  • Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
  • Response as assessed by MRI [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Desmoid Tumor
Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom,   Switzerland,   France,   Belgium,   Poland,   Germany
 
NCT00030680
EORTC-62991-22998, EORTC-62991, EORTC-22998
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: R. B. Keus, MD Arnhems Radiotherapeutisch Instituut
Study Chair: Thomas Schnabel, MD Klinikum der Stadt Ludwigshafen am Rhein
European Organisation for Research and Treatment of Cancer - EORTC
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP