NCT00030680

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_2

Geographic Reach
7 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

10.3 years

First QC Date

February 14, 2002

Last Update Submit

August 26, 2013

Conditions

Desmoid Tumor

Keywords

desmoid tumor

Outcome Measures

Primary Outcomes (1)

  • Local control as assessed by MRI at 3 years

Secondary Outcomes (2)

  • Toxicity as assessed by CTC 2.0

  • Response as assessed by MRI

Interventions

radiation therapyRADIATION

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (21)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Maastro Clinic - Locatie Maastricht

Maastricht, NL-6229 ET, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • R. B. Keus, MD

    Arnhems Radiotherapeutisch Instituut

    STUDY CHAIR

  • Thomas Schnabel, MD

    Klinikum der Stadt Ludwigshafen am Rhein

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

CH(1)GB(7)BE(2)FR(3)NL(6)DE(1)PL(1)