Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency

Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency - Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005559

Enrollment

Registered

2011-05-09

Start date

2011-04-01

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

gallbladder cancer

Interventions

administration of gemcitabine (1000mg/m2, div, over 30min, day1, 8), oral administration of tegafur/gimeracil/oteracil potassium (60-100mg/body, day1-14) and wash out period (day15-21), define as 1 cy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Diagnosed as gallbladder cancer (2) clinically stage 3, 4a, 4b in General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract (Japanese Society of Biliary Surgery, The 5th edition) (3) possibly resectable at diagnostic time (4) no previous chemotherapy for gallbladder cancer (5) no previous radiation therapy for gallbladder cancer (6) ECOG performance status (PS) is 0 or 1 (7) aged over 20 and less than 75 (8) Life expectancy > 3 months (9) Sufficient oral intake (10) good general condition (11) written informed consent (12) patient with judgement

Exclusion criteria

Exclusion criteria: (1) with severe infection (2) with fever >38 degrees C (3) Serious complications (e.g. severe heart desease, plumonary fibrosis, interstitial pneumonia) (4) past history of plumonary fibrosis, interstitial pneumonia or renal failure with dialysis) (5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy (6) with brain metastasis (7) with pericardial fluid (8)Pregnant or lactating women or women of childbearing potential (restrict lactating within 8 weeks after last Panitmumab administration) (9)Patient with severe drug allergy (10)Psychosis or severe mental disorder (11)Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Secondary

Measure	Time frame
Disease control rate (DCR) Progression free survival (PFS) Time to progression (TTP) Overall survival (OS) Median survival time (MST) adverse events rate	—

Primary

Measure	Time frame
Pathological curative resection rate	—

Countries

Japan

Contacts

Public ContactHiroki Hayashi

Tohoku University Hospital Hepato-Biliary Pancreatic Surgery

hiroki@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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