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Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer

Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer - Feasibility study of alternate day oral therapy with TS-1 in patients with unresectable pancreatic cancer or biliry tract cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014805
Enrollment
100
Registered
2014-08-11
Start date
2013-11-06
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

pancreatic cancer or biliary tract cancer

Interventions

S-1 chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily every monday, wednesday,friday and sunday for 6 weeks.

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)unresectable or recurrent pancreatic cancer or biliary tract cancer(include locally advanced or recurence) 2)standard chemotyerapy cannot be performed for some reason 3)sufficient function of important organs WBC: >=2,000/mm3 and <=12,000/mm3 Neut:>=1,000/mm3 Platelet: >=75,000/mm3 Hem: >=8.0g/dl sT.bil: <=3.0mg/dl AST, ALT: <= 150IU/L Ccr: >=30 ml/min/body 4)oral intake 5)written informed consent *ECOG P.S.:anything is OK

Exclusion criteria

Exclusion criteria: 1)administration contraindication of TS-1 2)with clinically important infection 3)with sever heart failure 4)with interstitial pneumonia or pulmonary fibrosis 5)with sever complication(Intestinal paralysis, Ileus, uncontrollable diabetes mellitus, Renal failure, Liver failure etc) 6)massive ascites fluid or pleural effusion 7)repetitive blood infusion for gastrointestinal hemorrhage 8)with mental disorder receving treatment or needing treatment 9)administered Flucytosine, Phenytoin, Warfarin potassium 10)pregnant women or lactating women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant 11)doctor's decision not to be registered to this study

Design outcomes

Primary

MeasureTime frame
Treatment completed rate

Secondary

MeasureTime frame
Overall survival Progeression-free survival Adverse events Time to treatment failure

Countries

Japan

Contacts

Public ContactMinoru Kitago

Department of Surgery, Keio University School of Medicine Department of Surgery

contact@keio-hpbts.jp03-3353-1211

Outcome results

None listed

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