Peripheral Primitive Fibromatosis (WS-RT Fibro)

Gustave Roussy

Status: Completed

Conditions: Peripheral Primitive Fibromatosis

Treatments: Other: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01801176

2011-A01188-33

2011/1774 (Other Identifier)

Details and patient eligibility

About

It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peripheral primitive fibromatosis
• Adults patients
• Peripheral primitive fibromatosis proved by biopsy
• Peripheral primitive fibromatosis R2 resected for which monitoring is decided
• MRI realized before inclusion
• Patient information and informed consent signed

Exclusion criteria

• Local recur
• Head and neck topography
• Primitive fibromatosis R0 or R1 resected
• Specific medical treatment of fibromatosis
• Patient already included in an other clinical trial with an experimental molecule
• Persons deprived of liberty
• Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons
• Previous history of cancer
• Counter indication to the realization of an MRI

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Initial monitoring group

Experimental group

Treatment:

Other: MRI