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Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II study

Adjuvant chemotherapy using gemcitabine+ CDDPin patients with resected biliary cancer, phase II study - Adjuvant chemotherapy using gemcitabine+ CDDP

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010501
Enrollment
28
Registered
2013-04-15
Start date
2013-04-01
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

resected bile duct cancer

Interventions

GEM+CDDP study

Sponsors

Dokkyo Medical Uniiversity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Bile duct cancer, pathological diagnosis as adenocarcinoma including adenoaquamous cell carcinoma, Stage is I-IV and R 0-1 resection. 2)Patients never had chemo-radiation therapy. 3) registration within 10 week after operation. 4)PS is 0-1 5)Good oral intake 6)no ascites and distance metastasis 7)clear of age limited 8)pass the criteria as below Hb 3000/mm3, WBC 3000/mm3, Plt 10,000/mm3 AST,ALT 150IU/L, T-Bli 3.0mg.dl, Cr 1.2mg/dl, 9) get informed consent

Exclusion criteria

Exclusion criteria: 1)Recurrence before registration 2)evidence of ascites and pleural effusion. 3)Evidence of cardiac effusion 4)Patients have pneumonia or pleural fibrosis. 5)Uncontrolled diarrhea 6)No evidence of OMI 3 months before registration. 7) No viral hepatitis 8)Uncontrolled DM 9)No BTF 2 week before registration. 10)There are not complication, such as cardiac, renal failure and/or liver failure, peptic ulcer, bowel pararitic disorder and stable for mental status. 11)no allergy. 12)No evidence of other organ malignancy.

Design outcomes

Primary

MeasureTime frame
disease free survival

Countries

Japan,Asia(except Japan),North America

Contacts

Public ContactMitsugi Shimoda

Dokkyo Medical Uniiversity Second department of Surgey

shimodamitsugi@hotmail.com0282-87-2158

Outcome results

None listed

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