Clinical Trial: Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Current Primary Outcome: Time to progression [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Dates:
Date Received: January 28, 2015
Date Started: November 2012
Date Completion: December 2015
Last Updated: January 30, 2015
Last Verified: January 2015