Randamized phase II trial of S-1+CDDP vs S-1+Docetaxel for advanced and/or recurrent gastric cancer

Randamized phase II trial of S-1+CDDP vs S-1+Docetaxel for advanced and/or recurrent gastric cancer - CS vs DS for GC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004780

Enrollment

200

Registered

2011-01-15

Start date

2011-01-01

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

advanced and/or recurrent gastric cancer

Interventions

Group A: 1 cycle is consited of 5 weeks used S-1+CDDP Group B: 1 cycle is consisted of 3 weeks used S-1 + Docetaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven adenocarcinoma of advanced gastric cancer(included esophagogastric junction) 2.Oral intake is possible 3.Presence of clear lesion for mesure 4.Performance status 0 to 1(ECOG) 5.Hemoglobin less than 8 g/dl, WBC counts is between 12000 and 4000 6.s-Creatinin level within normal limit 7.s-Bilirubin level within 1.5 X normal limit 8.S-GOT/GPT within 2.5Xnormal limit 9.Alkaline phosphatase within 2.5Xnormal limit 10.Without surgical influence 11.Witjout previous chemotherapy 12.Life expectancy is less than 3 months 13.Written informed conscent

Exclusion criteria

Exclusion criteria: 1.With active other cancer(excluded early colonic cancer) 2.With active bleeding 3.With ascites needed to exclude 4.metastasis to the brain 5.With peripheral neuropathy more than Grade 2 6.Interstitial pneumonia 7.With erethism history for 5-FU, TXT, polisorbate 80 8.Previouslly treated by chemoradiation 9.pregnancy and the person of intention to become pregnant 10. participated in other trial wiyhin 4 weeks 11.forbidden to use steroid

Design outcomes

Primary

Measure	Time frame
Time to progression	—

Secondary

Measure	Time frame
Median survival time Response rate The rate of adverse event Median rate of continuing therapy	—

Countries

Japan

Contacts

Public ContactHideo Matsumoto

Kawasaki Medical University Department of Digestive surgery

h-matsu@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

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