Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin for Advanced or Recurrent Gastric Cancer

Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin for Advanced or Recurrent Gastric Cancer - Feasibility study of outpatient chemotherapy with Capecitabine plus fractional Cisplatin

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006385

Enrollment

Registered

2011-09-22

Start date

2011-11-01

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 unresctable or recurrent gastric cancer

Interventions

Capecitabine plus fractional Cisplatin Level 1 Capecitabine:2000mg/m2/day p.o.(day1-14)+Cisplatin:30mg/m2 i.v.(day1,8) to be repeated every 3 weeks. Cisplatin is stepped up to 40mg/ m2.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histological and pathological confirmation of advanced or recurrent gastric adenocarcinoma. 2.Patient who are possible to be orally administrated. 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 1. 4.Life expectancy estimate 2 months, and more. 5.Adequate organ functions 6.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or breast-feeding women were excluded 2.Clinically significant cardiovascular disease 3.Evidence of central nervous system metastases 4.Major surgery or trauma in previous 4 weeks. 5.Inappropriate for this study judged by the attending physician

Design outcomes

Primary

Measure	Time frame
Safety [Incidence of dose limiting toxicity] Determine recommend dose	—

Secondary

Measure	Time frame
Progression free survival	—

Countries

Japan

Contacts

Public ContactHideki Bou

Nihon Medical School Musasikosugi Hospital Digestive Disease Center

044-733-5181

Outcome results

None listed

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