Skip to content

Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer.

Multicentral phase II study which verifies the completion rate of adjuvant S-1 chemotherapy in elderly patients with gastric cancer. - SISCO-GC 01

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011930
Enrollment
65
Registered
2013-11-01
Start date
2010-08-01
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

Gastric cancer

Interventions

To find out the safety and efficacy of the anti-cancer drug for elderly patients with gastric cancer

Sponsors

Tottori University, Divsion of Surgical Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histopathologically confirmed gastric cancer. 2)Curability A (R0). 3)Stage II (excluded T3N0) / III (Japanese classification). 4)No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis. 5)age:75. 6)No previous treatment(radiation therapy, chemotherapy, hormone therapy) for cancer except for the initial gastric resection for the primary lesion. 7)Oral administration is possible within 12 weeks after gastric resection. 8)Without any other severe diseases and adequate organ functions. Leu: >=4,000 /mm3, <=ULN Plt: >= 100,000 /mm3 T-bil: <= 1.5 g/dL ALT<=ULNx2.5 AST<=ULNx2.5 Ccr: >= 30 mg/min 9)With written informed consent.

Exclusion criteria

Exclusion criteria: 1)Active double cancer and/or past history of other cancer. 2)Flucytosin, phenytoin, or warfarin potassium administration. 3)Allergic more than and equal to grade3. 4)Patients with significant complications. 5)History of serious allergic reaction with S-1. 6)Men who have willing to become partner's pregnant. 7)Patients with HIV,HBV. 8)Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

MeasureTime frame
Feasibility (Treatment completion rate)

Secondary

MeasureTime frame
OS, RFS, Safety

Countries

Japan

Contacts

Public ContactHiroaki Saito

Tottori University Divsion of Surgical Oncology

sai10@med.tottori-u.ac.jp0859-38-6567

Outcome results

None listed

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