Clinical trial NCT00030680: Radiation Therapy in Treating Patients With Aggressive Fibromatoses
Official title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Desmoid Tumor
Keywords: desmoid tumor
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Local control as assessed by MRI at 3 years
Secondary outcomes:
measure: Toxicity as assessed by CTC 2.0
measure: Response as assessed by MRI
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: CHU de la Timone
city: Tuebingen
country: Germany
facility: Southwest German Cancer Center at Eberhard-Karls-University
city: Arnhem
country: Netherlands
facility: Arnhems Radiotherapeutisch Instituut
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastro Clinic - Locatie Maastricht
city: Rotterdam
country: Netherlands
facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center
city: Tilburg
country: Netherlands
facility: Dr. Bernard Verbeeten Instituut
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
state: England
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
affiliation: Arnhems Radiotherapeutisch Instituut
name: R. B. Keus, MD
role: STUDY_CHAIR
affiliation: Klinikum der Stadt Ludwigshafen am Rhein
name: Thomas Schnabel, MD
role: STUDY_CHAIR
References: