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OpenTrials
Completed

NCT Number: NCT01801176

Peripheral Primitive Fibromatosis

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.

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Key information

Conditions

Peripheral Primitive Fibromatosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

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 outcomes

  1. Progression Free Survival

    Time frame: assessed up to 3 years

Secondary outcomes

  1. Functional result

    Time frame: 1 year

    Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Acronym: WS-RT Fibro

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2013
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.