Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004)

Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004) - OGSG 0004

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000934

Enrollment

Registered

2007-12-08

Start date

2002-08-01

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

Patients with unresectable gastric cancer due to limited inavasion or metastasis.

Interventions

Day1...day8.......day21...day35....day42.......day56 (--TS-1---------).......(---TS-1--------) CDDP60mg/m2..................CDDP60mg/m2 .....................................2ws rest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable advanced gastric cancer due to limited inavasion or metastasis 2) cP0, CY0, cH0, cM0, and cT4, cN1, or cT2-4, cN2, cM1 (LYM) *cM1(LYM): distant lymph nodes in the abdomen which can be removed 3) biopsy by endoscopy showed gastric cancer, histologically 4) without prior chemotherapy 5) with measurable metastatic lymph nodes in RECIST criteria Measurable lesions: lesions larger than 10mm in spiral CT, or 20mm in common CT 6) without liver metastasis and/or peritoneal metastasis by abdominal echo, CT or laparoscopy. 7) without distant metastasis by blood examination, or chest X-ray, Without mediastinal lymph node metastasis by chast X-ray 8) age: =>20 and 75=> 9) Performance Status: 0-1 (ECOG criteria) 10) sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Hb >=8.0g/dl O Platelet: >= 100,000/mm3 O sGOT,sGPT: <100 IU/l O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= 1.2mg/dl O respiratory function: PaO2 in room air >=70 torr 11) written informed consent

Exclusion criteria

Exclusion criteria: 1) Under fresh bleeding from digestive tract 2) Patient who cannot take anticancer medicine orally due to gastrointestinal stenosis. 3) Type 4 gastric cancer 4) history of severe allergy against drug 5) under watery diarrhea 6) with sever disease on important organs (Infection, interstitial pneumonitis, pulmonary fibrosis, cardiac disease, renal dysfunction, liver dysfunction, DM controlled by insulin) 7) double cancer without carcinoma in citu 8) pregnant women or women who like to be pregnant 9) doctor' s dicision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
Response Rate(RECIST), probability on completion	—

Secondary

Measure	Time frame
Overall Survival, Resectability, Recurrence Mode	—

Countries

Japan

Contacts

Public ContactFurukawa Hiroshi

Sakai City Hospital Director

072-221-1700

Outcome results

None listed

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