CARDT: Cryoablation for Advanced and Refractory Desmoid Tumors

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT06113094

Collaborator

(none)

Enrollment

Location

41.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Desmoid Tumors

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Cryoablation for Advanced and Refractory Desmoid Tumors

Actual Study Start Date :

Jul 7, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria [at 6 months after cryoablation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Adult patient (≥18 years old)
Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research.