A Randomized Phase II study of S-1 and LV versus S-1, LV and L-OHP versus S-1 and CDDP in Patients with Advanced Gastric Cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221595

Enrollment

144

Registered

2011-09-26

Start date

2011-09-26

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

Gastric Cancer

Interventions

investigational material(s) Generic name etc : S-1/LV INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium, LV:folic acid Therapeutic category code : 422 Antimetabolic agents D

) was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients must be diagnosed as advanced gastric cancer - Age: 20 years or order - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 - Sufficient oral intake - Written informed consent - At least one measurable lesion by RECIST criteria

Exclusion criteria

Exclusion criteria: - Diarrhea - History or presence of severe pulmonary disease - History or presence of severe heart disease - Uncontrolled or severe diabetes - Severe complications(e.g., severe enteritis, severe stomatitis, gastrointestinal ulcer)

Design outcomes

Primary

Measure	Time frame
Response Rate (RR) To estimate response rate (RR) of S-1/LV therapy ,S-1/LV/L-OHP(SOL) therapy and S-1/CDDP therapy for patients with advanced gastric cancer.	—

Secondary

Measure	Time frame
Efficacy, Safety	—

Outcome results

None listed

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