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A exploratory phase II study of SOX followed by interval S-1 alone therapy for advanced gastric cancer: Stop and Go study

A exploratory phase II study of SOX followed by interval S-1 alone therapy for advanced gastric cancer: Stop and Go study - SOX followed by interval S-1 alone therapy for advanced gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023527
Enrollment
65
Registered
2016-12-01
Start date
2016-07-01
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 gastric cancer

Interventions

L-OHP,130mg/m2 DIV on day1 S-1,80 to 120mg/m2 PO on day1 to 14 1 cycle,3 weeks Continue for 4 cycles After 4 cycles,S-1 alone is continued 4 cycles

Sponsors

Department of Surgery, Gastroenterological Center, Medical Center, Yokohama City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma 2. Unresectable advanced gastric cancer 3. No massive ascites 4. No metastasis to the central nervous system 5. Patients with and without measurable lesion 6. Possible to oral intake 7. PS: 0 or 1 8. HER2 negative 9. No previous chemothearpy a. more than 24 weeks after S-1 administration completed b. no more than 1040mg/m2 of oxalipalatin 10. no lethal disfunction of the major organs 11. Who gave informed consent

Exclusion criteria

Exclusion criteria: 1. Drug allergy 2. Peripheral neurodisturvance 3. GI tract bleeding 4. Continuation of phenitoin, warfain 5. Uncontrollable infection 6. Interstitial pneumonia 7. Other cancers 8. DPD deficiency 9. Family planning 10. Inappropriate patients

Design outcomes

Primary

MeasureTime frame
progression-free survival

Secondary

MeasureTime frame
response rate, overall survival, toxicity

Countries

Japan

Contacts

Public ContactChikara Kunisaki

Medical Center, Yokohama City University Department of Surgery, Gastroenterological Center

s0714@med.yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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