GIST
Conditions
Keywords
Sunitinib Imatinib
Brief summary
To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib
Detailed description
Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy. Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of \<0.05 was considered statistically significant.
Interventions
DRUGImatinib 400mg
exposure 400 mg/day or 600mg/day,
DRUGSunitinib 37.5Mg Oral Capsule
exposure 37.5 mg/day, continuous taking, or 50 mg/day (4/2)
Sponsors
Peking University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. .Histopathological diagnosis of metastatic GIST. 2. . After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized. 3. . Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons. 4. at least 1 month after surgery for imatinib treatment or sunitinib treatment. 5. at least one imaging assessment was received after surgery. 6. . Complete clinical data and follow-up data.
Exclusion criteria
1. . Before operation, he was treated with sunitinib 2. . Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor. 3. . The treatment of imatinib or sunitinib after surgery was less than 1 month. 4. . Incomplete clinical data or follow-up data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency | 12 months | The curative effect was evaluated by measuring the unprogression-survival (PFS) each treatment group. |
| Security | 12 months | Clinical and laboratory toxicity/symptoms will be graded according to the nci-ctc toxicity criteria. |
| Molecular marker detection | 12 months | Gene mutation of c-kit/PDGFRA of imatinib resistance |
Countries
China
Contacts
Primary ContactLin Shen, MD
Backup ContactJian Li, MD
Outcome results
None listed