A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer (OGSG 0502)

A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer (OGSG 0502) - OGSG 0502

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000686

Enrollment

Registered

2007-04-23

Start date

2005-04-01

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

For patients with type 4 gastric cancer

Interventions

Treatment Methods A three course S-1 plus Paclitaxel (S-1[80mg/day] between day 1 and 14, and Paclitaxel [50mg/m2] on day 1 and 8, followed by 7 days rest) is administered before surgery.. Surgical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.histologically proven gastric cancer 2.type 4 gastric cancer 3.N0-2 (not bulky) 4.curative resection A or B in the preoperative diagnosis, 5.Thracotomy is not necessary 6.PS 0-1 in ECOG 7.Age: 20-75 yo 8.No history of prior surgery or chemotherapy for cancer 9.No obvious bleeding from lesion or no obstruction of intestine 10.sufficient oral intake 11.No organ failure detected by blood examination 12.CCr is over 50ml/min in Cockcroft-Gault method 13.No severe complications or no active double cancer except resected cancer in situ 14.written informed consent

Exclusion criteria

Exclusion criteria: 1.patients with severe diseases (non-treated ischemic cardiac disease, arrhythmia, liver cirrhosis, nterstitial pneumonia, fresh bleeding which needs transfusion, mental disorder, uncontrolled DM, intestinal obstruction, etc.) 2.febrile infection 3.allergy against polyoxyethylene-castor oil 4.under pregnancy or nursing 5.receiving steroids 6.receiving flucytosine, phenytoin or warfarin 7.doctors' decision

Design outcomes

Primary

Measure	Time frame
"The ratio of the patients who completed the regimen The ratio of administered dose to the planed dose."	—

Secondary

Measure	Time frame
Response Rate Overall Survival Disease Free Survival Histological CR	—

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