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Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"

Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))" - Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000031675
Enrollment
800
Registered
2018-03-12
Start date
2018-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

None listed

Sponsors

Japan Clinical Cancer Research Organization (JACCRO)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are registered in JACCRO GC-07 trial (UMIN 000010337), include the following: (1) Resected tumor tissue samples available (2) Approved to supply the tissue sample for this study by IRB.

Exclusion criteria

Exclusion criteria: (1) Patients who are considered as inadequate for study enrollment by investigators. (2) Patients who refuse the use of samples for study.

Design outcomes

Primary

MeasureTime frame
To evaluate if TUBB3 expression serves as a predictor for docetaxel by analyzing PFS and OS in docetaxel plus S-1 arm and S-1 alone arm according to TUBB3 status.

Secondary

MeasureTime frame
To evaluate associations of PFS and OS with TS, DPYD, OPRT, and TYMP expression in S-1 alone arm. To investigate correlation of PFS and OS with gene expression or mutations in each arm.

Countries

Japan

Contacts

Public ContactMasashi Fujii

Japan Clinical Cancer Research Organization (JACCRO) Research Office

gc07.dc@jaccro.or.jp03-6811-0433

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026