A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)

A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801) - A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002181

Enrollment

Registered

2009-07-10

Start date

2008-12-25

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 gastric cancer

Interventions

CPT-11 80mg/m2 is administered by drip infusion on day 1. TS-1 (BSA&lt

1.25 40mg/body/once,1.25&lt

=BSA&lt

1.5 50mg/body/once,BSA&gt

=1.5 60mg/body/ once) is administered twice a day orally between day 1 and day 21. It takes 35 days for the one course.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible criteria 1. primary gastric cancer diagnosed pathologically. 2. Final curability is B with D2 or D3 lymph node dissection 3. Stage IIIA(T2-N2,T3-N1 or T4-N0) or Stage IIIB(T3-N2 or T4-N1) 4. without any prior treatment for cancer 5. 4-8 weeks interval between surgical operation and following chemotherapy 6. age : 20-75 year old 7. performance status (ECOG):0-1 8. patients who can eat orally 9. without any severe disorder on the organs and with the data satisfied the following criteria measured within 2 weeks of registration 1) WBC >=4,000/mm3 and <12,000mm3 2) Neutrocyte >=2,000/mm3 3) Platelet >=100,000/mm3 4) Hg >=8.0g.dl 5) T.bil <=1.5mg/dl 6) GOT, GPT <=100 IU/l 7) sCr <=1.2mg/dl 10. written informed consent

Exclusion criteria

Exclusion criteria: Ineligible criteria 1.A fresh bleeding on the digestive tract 2.Severe allergy against medicines or history of allergy 3.with active double cancer 4.with uncontrollable cavity fluid 5.with some infectious diseases and/or febrile condition 6.with brain metastases 7.with some disorders on ECG 8.with heart diseases such as congestive heart failure, symptomatic coronary dysfunction, uncontrollable arrhythmia, infarction/history of infarction 9.with liver cirrhosis and/or active hepatitis 10.with DM uncontrollable 11.with severe pulmonary diseases such as interstitial pneumonia,Pulmonary fibrosis 12.uncontrollable diarrhea 13.under intestinal paralysis or ileus 14.patients with psychological disorder who seems difficult to undergo treatment 15. under medication of ATAZANABIL 16. under continuous medication of steroids 17. with continuous medication of fluoro-pyrimidine, flusitosine, fenitoin,and/or Warfarin 18. pregnant and/or nursing women or patients who like to have children 19. patient who seems difficult to undergo protocol treatment

Design outcomes

Primary

Measure	Time frame
Patients ratio with 4 course completion	—

Secondary

Measure	Time frame
1.Patients ratio with one year course completion 2.Incidence of adverse events 3.Recurrence Free Survival 4. Overall Survival	—

Countries

Japan

Contacts

Public ContactFujitani Kazumasa

National Hospital Organization Osaka National Hospital Dpt. surgery

06-6942-1331

Outcome results

None listed

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