A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 17, 2017
June 1, 2014
1.9 years
February 7, 2011
November 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose
To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1)
Secondary Outcomes (1)
Number of Participants with dose limiting toxicity
At the end of adjuvant chemotherapy (6 months)
Study Arms (1)
gemcitabine , cisplatin
EXPERIMENTALInterventions
Dose of gemcitabine and cisplatin and treatment schedule
Eligibility Criteria
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
- PS0 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kobe University Graduate School of Medicine
Kobe, 650-0017, Japan
Related Publications (1)
Toyoda M, Ajiki T, Fujiwara Y, Nagano H, Kobayashi S, Sakai D, Hatano E, Kanai M, Nakamori S, Miyamoto A, Tsuji A, Kaihara S, Ikoma H, Takemura S, Toyokawa H, Terajima H, Morita S, Ioka T. Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1004). Cancer Chemother Pharmacol. 2014 Jun;73(6):1295-301. doi: 10.1007/s00280-014-2431-y. Epub 2014 Mar 11.
PMID: 24614947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tetsuo Ajiki, MD, PhD
Kobe University Graduate School of Medicine
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
February 7, 2011
First Posted
February 17, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Study Completion
June 1, 2013
Last Updated
November 17, 2017
Record last verified: 2014-06