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

NCT01713387 | Completed Phase 1 DMC

• 2 other identifiers: KHBO1202UMIN000007454
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1 combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy

Conditions

Biliary Tract Cancer

Keywords

adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  To establish the maximum tolerated dose of gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy

  6 weeks

Secondary Outcomes (1)

• Number of Participants with dose limiting toxicity

  At the end of adjuvant chemotherapy (6 months)

Study Arms (1)

gemcitabine , S-1

EXPERIMENTAL

Level-2 Gem 800mg/msq, S-1 50mg/msq Level-1 Gem 800mg/msq, S-1 65mg/msq Level 1 Gem 1000mg/msq, S-1 65mg/msq Level 2 Gem 800mg/msq, S-1 80mg/msq

Drug: Gemcitabine, S-1

Interventions

Gemcitabine, S-1 DRUG

Dose of gemcitabine and S-1 and treatment schedule

Also known as: Gemcitabine;gemzer , S-1;TS-1

gemcitabine , S-1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biliary tract cancer (BTC) with more than stage IB
• BTC undergoing R0 or R1 resection without major hepatectomy
• Older than 20 years old
• PS 0 or 1
• No treatment other than surgery
• No dysfunction of main organs
• Possible oral intake
• Treatment start; after 4 weeks and within 12 weeks after surgery
• Obtained written informed consent

You may not qualify if:

• Patients with resection of major hepatectomy
• Patients with double cancers
• Patients having severe allergy
• Patients with severe organ dysfunction
• Patients with active infectious disease
• Pregnancy
• Patients with severe psychological disease
• Patients seem inadequate for this study by investigators

Sponsors & Collaborators

• Kansai Hepatobiliary Oncology Group: lead

Study Sites (1)

Kansai Medical University

Hirakata, Osaka, 573-1191, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hideyoshi Toyokawa, MD, PhD

  Kansai Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: October 24, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: March 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-08

Locations

JP (1)