Desmoid Type-fibromatosis Clinical Trial
Official title:
Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets
This is a prospective study evaluating the activity and the safety of toremifene in patients
with primary or recurrent sporadic DTs.
Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will
start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will
be performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale
(VAS) every 3 months for the first and second year, twice yearly thereafter. Response will
be evaluated either by RECIST and/or symptomatic relief.
This is a prospective study evaluating the activity and the safety of toremifene in patients
with primary or recurrent sporadic DTs.
Patients will be enrolled after the histological confirmation of DTs on biopsy performed at
the investigators institution or after the pathological review of tissue specimen obtained
via needle biopsy or surgical excision (in case of recurrence) performed elsewhere. A new
biopsy will be performed if the amount of tissue will not be sufficient for
immunohistochemical analysis. Patients will start at 60 mg daily and dose-escalate to 180 mg
upon progression. Disease assessment will be performed by contrast-enhanced MRI or CT scan,
pain evaluation by a visual analog scale (VAS) every 3 months for the first and second year,
twice yearly thereafter. Response will be evaluated either by RECIST and/or symptomatic
relief.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment