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Completed

NCT Number: NCT00030680

Radiation Therapy in Treating Patients With 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Primary outcomes

  1. Local control as assessed by MRI at 3 years

Secondary outcomes

  1. Toxicity as assessed by CTC 2.0

  2. Response as assessed by MRI

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2003
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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