To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

Sponsor
Peking University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03424876
Collaborator
(none)
60
1
14.2
4.2

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
  • Drug: Imatinib 400mg
  • Drug: Sunitinib 37.5Mg Oral Capsule

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

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Cohort Study
Actual Study Start Date :
Jun 2, 2017
Anticipated Primary Completion Date :
Jun 2, 2018
Anticipated Study Completion Date :
Aug 8, 2018

Arms and Interventions

Arm Intervention/Treatment
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,

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

  1. Efficiency [12 months]

    The curative effect was evaluated by measuring the unprogression-survival (PFS) each treatment group.

  2. Security [12 months]

    Clinical and laboratory toxicity/symptoms will be graded according to the nci-ctc toxicity criteria.

  3. Molecular marker detection [12 months]

    Gene mutation of c-kit/PDGFRA of imatinib resistance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier:
NCT03424876
Other Study ID Numbers:
  • G0602
First Posted:
Feb 7, 2018
Last Update Posted:
Mar 1, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shen Lin, Professor, Peking University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2018