Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287755
Status:
COMPLETED
Last Update Posted:
2011-06-29
First Post:
2006-02-03
Brief Title:
Clinical Trial of Chemosensitivity Test
Sponsor:
Japan Clinical Cancer Research Organization
Organization:
Japan Clinical Cancer Research Organization
Study Overview
Official Title:
Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy S-1 After Gastric Surgery
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
Detailed Description:
Patients clinical Stage III gastric cancer patients Informed consent will be obtained before surgery Eligible patients surgical Stage II IIIA and IIIB gastric cancer patients Chemosensitivity test The surgical specimen will be sent Mitsubishi BCL Co Ltd to be tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and dihydropyrimidine dehydrogenase mRNA The test results will be blinded for the doctors on duty
Treatment All the patients will be treated with S-1 at a dose of 80 mgm2 bid for 4 weeks followed by 2 weeks rest The treatment will be continued until the recurrence or 1 year after operation
Primary endpoint 3-years disease-free survival rate Secondary endpoint 3-years overall survival rate and side effect CTCAE v30 Evaluation of chemosensitivity test The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs
Hypothesis The responder detected by CD-DST andor TS DPD mRNA will have a favorable survival outcome comparing with resistant cases
Treatment All the patients will be treated with S-1 at a dose of 80 mgm2 bid for 4 weeks followed by 2 weeks rest The treatment will be continued until the recurrence or 1 year after operation
Primary endpoint 3-years disease-free survival rate Secondary endpoint 3-years overall survival rate and side effect CTCAE v30 Evaluation of chemosensitivity test The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs
Hypothesis The responder detected by CD-DST andor TS DPD mRNA will have a favorable survival outcome comparing with resistant cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GC-04 | None | None | None |