Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer

Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer - Randomized controlled trial of gemcitabine administration schedule in patients undergoing curative resection of biliary cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001020

Enrollment

Registered

2008-02-11

Start date

2008-02-01

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

Biliary cancer

Interventions

Adjuvant chemotherapy with 6 cycle of gemcitabine on days 1, 8, and 15 every 4 weeks Adjuvant chemotherapy with 9 cycle of gemcitabine on days 1 and 8 every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histologically verified biliary cancer who had curetive resection (>=stage II) and no prior therapy. Performance Status 0-1. Adequate organ function (Hb >=10g/dL, Leukocyte >=4x103/uL, Neutrophil >=2x103/uL, Platelets>=100x103/uL, AST,ALT <=4xULN, Bil <=2xULN, creatine<=ULN. Tolerable to chemotherapy within 4-12 weeks after surgery. Written informed consent.

Exclusion criteria

Exclusion criteria: Pulmonary fibrosis or interstitial pnumonia with radiologycal or clinical findings Uncontrollable pleural effusion or ascites or edema. Active severe infection severe complication (e.g. heart failure, renal failure, liver failure, GI ulcer, ileus uncontrollabe diabetes mellitus) severe drug allergy With uncured other malignancies Psychiatric disorder Pregnant or women wishing for baby.

Design outcomes

Primary

Measure	Time frame
Feasibility, safety, and disease free survival	—

Countries

Japan

Contacts

Public ContactShogo Kobayashi

Osaka University GI Surgery

s-kobayashi@umin.ac.jp

Outcome results

None listed

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