To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Arm A Imatinib 400 mg/day or 600mg/day, and within 6 weeks after surgery, continuous treatment was not tolerated until tumor progression, recurrence or adverse reactions were not tolerated. |
Drug: Imatinib 400mg
exposure 400 mg/day or 600mg/day,
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Arm B Sunitinib 37.5 mg/day, continuous taking, or 50 mg/day (4/2), began within 6 weeks after surgery, and was continuously administered until tumor progression, recurrence or adverse reactions were not tolerated |
Drug: Sunitinib 37.5Mg Oral Capsule
exposure 37.5 mg/day, continuous taking, or 50 mg/day (4/2)
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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.Histopathological diagnosis of metastatic GIST.
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. After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
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. Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
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at least 1 month after surgery for imatinib treatment or sunitinib treatment.
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at least one imaging assessment was received after surgery.
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. Complete clinical data and follow-up data.
Exclusion Criteria:
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. Before operation, he was treated with sunitinib
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. Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
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. The treatment of imatinib or sunitinib after surgery was less than 1 month.
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. Incomplete clinical data or follow-up data.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
Sponsors and Collaborators
- Peking University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM. SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther. 2003 May;2(5):471-8.
- Li J, Gao J, Hong J, Shen L. Efficacy and safety of sunitinib in Chinese patients with imatinib-resistant or -intolerant gastrointestinal stromal tumors. Future Oncol. 2012 May;8(5):617-24. doi: 10.2217/fon.12.29.
- Rubin BP, Singer S, Tsao C, Duensing A, Lux ML, Ruiz R, Hibbard MK, Chen CJ, Xiao S, Tuveson DA, Demetri GD, Fletcher CD, Fletcher JA. KIT activation is a ubiquitous feature of gastrointestinal stromal tumors. Cancer Res. 2001 Nov 15;61(22):8118-21.
- G0602