Peripheral Primitive Fibromatosis

Peripheral Primitive Fibromatosis Clinical Trial

— WS-RT Fibro  

Official title:

Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01801176
• Other study ID #: 2011-A01188-33
• Secondary ID: 2011/1774
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2013
• Last updated: June 8, 2016
• Start date: May 2012
• Est. completion date: May 2018

Study information

• Verified date: June 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fibroma
• Peripheral Primitive Fibromatosis

Intervention

Other:
• MRI
MRI every 3 months during the first year and then every 6 months during the second year and then one MRI up to 36 months

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		assessed up to 3 years	No
Secondary	Functional result	Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation	1 year	No