A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)

A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604) - A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000714

Enrollment

Registered

2007-05-17

Start date

2007-05-01

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

Stage IIIA or stage IIIB gastric cancer

Interventions

DXT 40mg/m2 is administered by drip infusion on day 1. TS-1 80 mg/m2/day is administered orally between day 1 and day 14. It takes 21 days for the one course

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically proven gastric carcinoma 2. D2 lymph node dissection and curative resection (R0) at the prior surgery 3. patients with stage IIIA or stage IIIB gastric cancer 4. age: 20<= and =<80 years old 5. PS(ECOG): 0 &#8211; 1 6. without any prior radiation therapy, chemotherapy, or hormone therapy 7. patients who can take medicine orally 8. without any other severe diseases WBC 4,000<= and => 12,000/mm3 Neutrocyte 2,000mm3<= Hemoglobin 9.0 g.dl <= Platelet 100,000/mm3 <= Total bilirubin 1.5 mg/dl => AST, ALT normal range in each institute Serum creatinin 1.2 mg/dl >= Creatinin clearance 60 ml/min/body <= **Cockcroft-Gault method is available 9. written informed consents

Exclusion criteria

Exclusion criteria: 1. with double cancer and/or multiple cancer 2. patients who cannot take TS-1 3. patients who need flucitosine, fenitoin or warfarin 4. with allergic history against medicines 5. with severe allergic response against polysolbate 80 6. without any disorder on the chest X-ray or CT, or interstitial pneumonitis or pulmonary fibrosis 7. with other severe diseases (intestinal paralysis, intestinal obstruction, uncontrolled DM, cardiac failure, or liver dysfunction) 8. watery diarrhea 9. pregnant and/or nursing women 10. men who need their children in future 11. liver cirrhosis or active hepatitis 12. cavity fluid which should be taken out 13. doctors' stop not to register to the study

Design outcomes

Primary

Measure	Time frame
The ratio of the patients who completed the course	—

Secondary

Measure	Time frame
Incidence of adverse events, Time to recurrence, survival, the ratio of the patients who completed the course of TS-1 in a year	—

Countries

Japan

Contacts

Public ContactHiroshi Furukawa

Kinki University Faculty of Medicen Department of surgery

072-366-0221

Outcome results

None listed

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