Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced biliary tract cancer.

Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced biliary tract cancer. - gemcitabine/radiation combination therapy and gemcitabine monotherapy in biliary tract cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000625

Enrollment

Registered

2007-03-03

Start date

2007-03-01

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

locally advanced unresectable biliary tract cancer

Interventions

Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15. The cycle was repeated every 4 weeks until disease progression or unacceptable toxicity is remarked. 5 week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with pathologically confirmed locally advanced biliary tract cancer 2.Patients of 20 years old and above 3.Patients without simultaneous other cancers 4.Patients without history of prior therapy for primary disease, excluding biliary drainage 5.ECOG Performance status 0-2 6.Patients with adequate organ function 7.Patients without concomitant diseases required therapy 8.Informed consents are obtained from all patients

Exclusion criteria

Exclusion criteria: 1.Patients with interstitial pneumonia, pulmonary fibrosis. 2.Patients with intractable diabetes mellitus, liver dysfunction, angina pectoris, or myocardinal infarction within months after onset. 3.Patients with suspicious of serious infection, or serious infection. 4.Patients with pregnacy, during lactation, or patient with hope of pregnant 5.Patients with severe drug allergy 6.Patients with severe concomitant disease 7.Patients with pleural effusion or ascites 8.Patients with active multiple cancers 9.The patients judged inappropriate in enrolling into this study by the investigators

Design outcomes

Primary

Measure	Time frame
a survival rate for 1 year	—

Secondary

Measure	Time frame
response rate/ safety	—

Countries

Japan

Contacts

Public ContactIchiro Yasuda

Gifu University Hospital First Dept. Internal Medicine

YASUDAIC@aol.com058-230-6308

Outcome results

None listed

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