Spots Global Cancer Trial Database for Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy
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Trial Identification
Brief Title: Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy
Official Title: A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib
Study ID: NCT01865565
Conditions
Interventions
Study Description
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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Contact Details
Name: Chun-Nan Yeh, MD
Affiliation: Chang Gung Memorial Hospital, Linkou, Taiwan.
Role: STUDY_CHAIR
Name: Jen-Shi Chen, MD.
Affiliation: Chang Gung Memorial Hospital, Linkou, Taiwan.
Role: PRINCIPAL_INVESTIGATOR
Name: Yen-Yang Chen, MD.
Affiliation: Chang Gung Memorial Hospital, Kaoshung, Taiwan.
Role: PRINCIPAL_INVESTIGATOR
Name: Kun-Chun Chiang, MD.
Affiliation: Chang Gung Memorial Hospital, Keelung, Taiwan.
Role: PRINCIPAL_INVESTIGATOR
Name: Liang-Mou Kuo, MD.
Affiliation: Chang Gung Memorial Hospital, Cha-Yi, Taiwan.
Role: PRINCIPAL_INVESTIGATOR
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