NCT01865565

Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy

A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Gastrointestinal Stromal Tumor

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-31
• Completion: 2017-12-31
• First posted: 2013-05-31
• Last updated: 2018-08-09

Locations

1 site across 1 country: Taiwan