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Report for Clinical Trial NCT02413736

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST With a High Risk for Recurrence: A Randomised Phase III Study

In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST) and have been treated with adjuvant imatinib for 3 years after surgery will be randomly allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop imatinib (Arm B). The study participants are required to have histologically verified GIST with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at surgery and 3 years of adjuvant imatinib. The high risk of GIST recurrence is defined as one of the following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the microscope, non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture. Study participants allocated to Arm A will receive imatinib 400 mg/day for 24 months after the date of randomization. All study participants will be followed up using blood tests and computerized tomography (or MRI) of the abdomen. The computerized tomography examinations will be performed at 6 month intervals. A total of 300 patients will be entered to the study. The study hypothesis is that adjuvant imatinib given for a total of 5 years may prevent some of the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years, and there may be a difference in the rate of GIST recurrence between the two groups.

NCT02413736 Sarcoma
HPO:Sarcoma Soft tissue sarcoma

1 Interventions

Name: Imatinib

Description: Imatinib 400 mg/day
Type: Drug
Group Labels: 1


Primary Outcomes

Description: Time from the date of randomization to GIST recurrence or death.

Measure: Recurrence-free survival

Time: 5 years

Secondary Outcomes

Description: Time from the date of randomization to death.

Measure: Overall survival

Time: 5 years

Description: Time from the date of randomization to the date of death considered to be caused by GIST.

Measure: GIST-specific survival

Time: 5 years

Description: Adverse effects considered to be related to the treatment.

Measure: Adverse effects

Time: 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 D842V

- Presence of a substitution mutation at PDGFRA codon D842 (usually D842V). --- D842V ---

HPO Nodes