Radiation Therapy in Treating Patients With Aggressive Fibromatoses - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 14, 2002

Last Updated Date

February 6, 2009

Start Date ^†

November 2001

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00030680 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Toxicity as assessed by CTC 2.0
Response as assessed by MRI

Descriptive Information

Brief Title ^†

Radiation Therapy in Treating Patients With Aggressive Fibromatoses

Official Title ^†

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

Brief Summary

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.

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment

Condition ^†

Desmoid Tumor

Intervention ^†

Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Belgium, France, Germany, Netherlands, Poland, Switzerland, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00030680

Responsible Party

Secondary IDs ^††

EORTC-62991, EORTC-22998

Study Sponsor ^†

European Organization for Research and Treatment of Cancer

Collaborators ^††

Investigators ^†

Investigator:	R. B. Keus, MD	Arnhems Radiotherapeutisch Instituut
Investigator:	Thomas Schnabel, MD	Klinikum der Stadt Ludwigshafen am Rhein

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.