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Trial record 1 of 1 for:    NCT01801176
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Peripheral Primitive Fibromatosis (WS-RT Fibro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01801176
Recruitment Status : Unknown
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : February 28, 2013
Last Update Posted : June 9, 2016
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Primitive Fibromatosis Other: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : May 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: Initial monitoring group 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

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: assessed up to 3 years ]

Secondary Outcome Measures :
  1. Functional result [ Time Frame: 1 year ]
    Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01801176

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Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Sylvie BONVALOT, MD    0142114383 ext +33   
Contact: Thibaud MOTREFF    0142116643 ext +33   
Principal Investigator: Sylvie BONVALOT, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT01801176     History of Changes
Other Study ID Numbers: 2011-A01188-33
2011/1774 ( Other Identifier: CSET number )
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
proved by biopsy

Additional relevant MeSH terms:
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Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type