Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy

Completed

• Conditions: Gastrointestinal Stromal Tumor

• Registration Number: NCT01865565
• Lead Sponsor: Chang Gung Memorial Hospital

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)

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Primary Completion: 2016-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival	five years	Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with CT scan.

Secondary Outcome Measures

Name	Time	Method
Surgical morbidity and mortality and safety follow up	five years	surgical morbidity: morbidity related to surgical procedure surgical mortality: mortality related to surgical procedure safety: adverse events related imatinib according to NIH toxicity evaluation criteria
Overall survival (OS)	five years	Overall survival (OS) will be measured from after administration of imatinib mesylate and death as the end point of the study, whatever the cause. Alive patients will be censored at the date of last follow-up. Causes of death will be recorded.
R0 resection rate	three years	all the participants
Objective response rate, tumor shrinkage rate	three years	all the participants
Correlation of PK with response	three years	check PK (trough level of imatinib)of all the participants at first month and every three months later to correlate with the response and check PK (peak level of imatinib) of all the participants who had adverse events

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan