A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404)

A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404) - OGSG0404

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000661

Enrollment

Registered

2007-04-05

Start date

2004-09-01

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

Dose by Ccr: Ccr 80ml/min&lt

= body surface 1.5m2&lt

=:120mg/body/day, 1.25-1.5:100mg/body/day, 1.25&gt

:80mg/Body/day Ccr 50mg/min&lt

= and 80mg/min&gt

:1 dose down(1.5m2&lt

=:100mg/body/day, 1.25-1.5: 80mg/body/day, 1.25&gt

: 50mg/body/day) Ccr 30mg/min&lt

= and 50mg/min&gt

:2 dose down(1.5m2&lt

=: 80mg/body/day, 1.25-1.5: 50mg/body/day, 1.25&gt

: 40mg/body/day) TS-1 is administered 4 weeks continuously and 2 weeks off, sebsequently

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically proven gastric cancer 2. with measurable lesion on CT 3. aged over 75years old 4. PS:0-2 5. patients who can eat orally 6. Labo Data 1) WBC 4,000<= and <12,000 mm3 2) Neutrocyte 2,000mm3<= 3) Platelet 100,000mm3<= 4) Hemoglobin 8.0 g/dl<= 5) AST,ALT <=100 IU/L or <=150 IU/L for patients with liver metastasis 6) Total Bil.: within normal range in each institute 7) serum creatinin <=1.2 mg/dl 8) expected creatinin clearance: >=30 mg/min by Cockcroft-Gault 7. without prior treatment(radiation therapy, chemotherapy or hormon therapy). with postoperative adjuvant chemotherapy which has completed 6 months before 8. patients expected more than 3 months survival 9. with written informed consent 10. expected sufficient compliance 11. with MMSE data before treatment

Exclusion criteria

Exclusion criteria: 1. with active double cancer 2. with severe other diseases(intestinal paralysis, ileus, intersitial pneumonitis or plumonary fibrosis, uncontrolled DM, cardiac failure, renal dysfunction, liver dysfunction, respiratory dysfunction) 3. severe ascites and/or pulmonary fluid 4. metastasis on central nerve system with symptom 5. fresh bleeding on digestive tract 6. with severe ischemic cardiac disease which needs treatment 7. hypersensitive response to TS-1 8. with severe bone marrow supplession, renal dysfunction or liver dysfunction 9. under administration of flucytosine 10. patients who underwent postoperative adjuvant chemotherapy of TS-1 11. doctor's exclusion due to some reason

Design outcomes

Primary

Measure	Time frame
Aanti-cancer effects (Response Rate, Response Period)	—

Secondary

Measure	Time frame
Feasibility (Incidence of Adverse Events), Overall Survival, Progression Free Survival, Time to Treatment Failure, Relationship to the score of MMSE	—

Countries

Japan

Contacts

Public ContactImamura Hiroshi

Toyonaka City Hospital Department of Surger

imamurahiroshisakai@yahoo.co.jp06-6843-0101

Outcome results

None listed

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

A phase II study on TS-1 treatment for aged patients (&lt;=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404)