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Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer:exploratory clinical trial

Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer:exploratory clinical trial - Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer (SPEC trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038357
Enrollment
30
Registered
2019-10-23
Start date
2019-10-25
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

8 courses of S-1 chemotherapy

Sponsors

Takatsuki general hospital
Lead Sponsor
Graduate School of Medicine, Kyoto University Japanese Red Cross Wakayama Medical Center Kobe City Medical Center General Hospital Hyogo Cancer Center Gastrointestinal Center, SANO HOSPITAL Akashi Medical Association Akashi Medical Center Ise Red Cross Hospital Kobe University Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients underwent non curative ESD for gastric cancer who refuse additional gastrectomy 2) Age from 20 to 85 years old 3) European Cooperative Oncology Group(ECOG) performance status of 0 or 1 4) No previous treatment of chemotherapy or radiation therapy for any neoplasms 5) Enough oral intake 6) Preserved organ function as follows 1 neutrophile count >=1,500/mm3 2 hemoglobin >=8.0 g/dL 3 platelet count >=75,000/mm3 4 AST=<100 IU/L 5 ALT=<100 IU/L 6 total bilirubin =<2.0 mg/dL 7 creatinine clearance (CCr) >=40 mL/min 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1)Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shoter, except mucosal cancer treated by endoscopic resection 2) previous gastrectomy 3) Infection requiring systemic treatment 4) Women expecting pregnancy, in pregnancy, in possible pregnancy or in breast feeding 5) Male expecting partner's pregnancy 6) Severe mental disease 7) Under treatment by flucytosine, phenytoin, or warfarin potassium 8) Uncontrolled diabetes mellitus 9) severe lung disease (Interstitial pneumonia, severe emphysema and so on) 10) unstable angina or myocardial infarction within 6 months

Design outcomes

Primary

MeasureTime frame
Relapse-free survival

Secondary

MeasureTime frame
overall survival, Disease specific survival, Rate of treatment continuation, Adverse event

Countries

Japan

Contacts

Public ContactHiroaki Sawai

Takatsuki general hospital Division of Gastroenterology

shiroaki23@gmail.com072-681-3801

Outcome results

None listed

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