Gastrointestinal Stromal Tumors
Conditions
Keywords
Gastrointestinal,, stromal,, neoadjuvant,, imatinib,, mesylate,, pre-operatory
Brief summary
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.
Interventions
DRUGimatinib mesylate
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients with age between 18 and 80 years * diagnosis of GIST not previously treated * Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)
Exclusion criteria
* presence of metastatic disease * use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response using the RECIST criteria | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | 16 weeks |
| Time and duration of response | 16 weeks |
| Time to treatment failure | 16 weeks |
| Overall survival | 16 weeks |
Countries
Brazil
Outcome results
None listed