Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 16 and over Other EORTC-62991 EORTC-22998, NCT00030680

Objectives

1. Determine the efficacy of moderate-dose radiotherapy, in terms of local control, in patients with aggressive fibromatoses.
2. Determine the acute and late side-effects of this regimen in these patients.

Entry 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

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

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

Expected Enrollment

A total of 40 patients will be accrued for this study within 3 years.

Outcomes

Local control as assessed by MRI at 3 years

Toxicity as assessed by CTC 2.0
Response as assessed by MRI

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

R. B. Keus, MD, Study coordinator		Ph: 31-26-371-2470 Email: r.keus@arnhemrti.nl
Thomas Schnabel, MD, Study coordinator		Ph: 49-621-503-3800

Registry Information
Official Title		Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Trial Start Date		2001-11-15
Registered in ClinicalTrials.gov		NCT00030680
Date Submitted to PDQ		2001-12-12
Information Last Verified		2008-04-13

Back to Top