A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Stromal Tumor
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- progression free survival
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective, multicenter, open, observational study in evaluation of safety and efficacy of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. The study will include an up to 28-day screening period, followed by receiving imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after surgery.
Detailed Description
Primary Objective * To observe the safety of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. Secondary Objective * Progression-free survival (PFS) in resected patients during follow up * R0 resection rate * objective response rate, tumor shrinkage rate * Correlation of mutation status with response * Correlation of PK with response * Surgical morbidity and mortality and safety follow up * Quality of life * Overall survival (OS)
Investigators
Chun-Nan Yeh
MD, Associate Professor, Dept. of General Surgery.
Chang Gung Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
progression free survival
Time Frame: five years
Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with CT scan.
Secondary Outcomes
- R0 resection rate(three years)
- Objective response rate, tumor shrinkage rate(three years)
- Surgical morbidity and mortality and safety follow up(five years)
- Correlation of PK with response(three years)
- Overall survival (OS)(five years)