A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansai Hepatobiliary Oncology Group
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

1. Biliary tract cancer (BTC) with more than stage IB

2. BTC undergoing R0 or R1 resection without major hepatectomy

3. Older than 20 years old

4. PS0 or 1

5. No treatment other than surgery

6. No dysfunction of main organs

7. Possible oral intake

8. Treatment start; after 4 weeks and within 12 weeks after surgery

9. Obtained written informed consent

Exclusion Criteria:

1. Patients with resection of major hepatectomy

2. Patients with double cancers

3. Patients having severe allergy

4. Patients with severe organ dysfunction

5. Patients with active infectious disease

6. Pregnancy

7. Patients with severe psychological disease

8. Patients seem inadequate for this study by investigators