Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer
Information source: Gyeongsang National University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Biliary Tract Cancer; Locally Advanced Biliary Tract Cancer
Intervention: Gemcitabine, Cisplatin (Drug); S-1, Cisplatin (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Gyeongsang National University Hospital Official(s) and/or principal investigator(s):
Hyuk-Chan Kwon, M.D., Principal Investigator, Affiliation: Dong-A University Hospital
Jung Hun Kang, M.D., Study Director, Affiliation: Gyeongsang University Hospital
Overall contact:
Jung Hun Kang, M.D., Phone: 82-10-9344-0543, Email: newatp@gnu.ac.kr
Summary
The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and
S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.
Clinical Details
Official title: Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to progression
Secondary outcome: Response rate Overall survival Safety profile
Detailed description:
Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to
the difficulty associated with performing clinical trials in this field.
Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for
BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National
Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based
or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age : older than 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Histologically confirmed adenocarcinoma of the biliary tract
- Metastatic or unresectable biliary cancer
- No prior chemotherapy for biliary cancer
- A patient with at least one measurable primary lesion of which the diameter is
confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
- Adequate bone marrow, liver, renal function
Exclusion Criteria:
- A patient with no measurable disease
- A patient who received previous palliative chemotherapy for biliary cancer
- A patient who received adjuvant chemotherapy for biliary cancer within 1year
- A patient with previous active or passive immunotherapy.
- A pregnant or lactating patient
Locations and Contacts
Jung Hun Kang, M.D., Phone: 82-10-9344-0543, Email: newatp@gnu.ac.kr
Gyeongsang University Hospital, Jinju, Gyeongsang Namdo 660-702, Korea, Republic of
Additional Information
Starting date: July 2010
Last updated: April 12, 2010
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