Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer
This study has been terminated.
(Planning for randomized phase III trial for this issue.)
Sponsor:
Gyeongsang National University Hospital
Collaborators:
Samsung Medical Center
Dong-A University
Chung-Ang University
Information provided by:
Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:
NCT01096745
First received: March 30, 2010
Last updated: June 21, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Biliary Tract Cancer Locally Advanced Biliary Tract Cancer |
Drug: Gemcitabine, Cisplatin Drug: S-1, Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Gyeongsang National University Hospital:
Primary Outcome Measures:
- Time to progression [ Time Frame: From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate Overall survival Safety profile [ Time Frame: Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 78 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gemcitabine/Cisplatin |
Drug: Gemcitabine, Cisplatin
D1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks
Other Names:
|
|
Experimental: S-1/Cisplatin
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
|
Drug: S-1, Cisplatin
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Other Names:
|
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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096745
Locations
| Korea, Republic of | |
| Gyeongsang University Hospital | |
| Jinju, Gyeongsang Namdo, Korea, Republic of, 660-702 | |
Sponsors and Collaborators
Gyeongsang National University Hospital
Samsung Medical Center
Dong-A University
Chung-Ang University
Investigators
| Principal Investigator: | Hyuk-Chan Kwon, M.D. | Dong-A University Hospital |
| Study Director: | Jung Hun Kang, M.D. | Gyeongsang University Hospital |
More Information
No publications provided
| Responsible Party: | Jung Hun Kang/Assisstant Professor, Gyeongsang National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01096745 History of Changes |
| Other Study ID Numbers: | GNUHIRB-2010-5 |
| Study First Received: | March 30, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Gyeongsang National University Hospital:
|
Gemcitabine Cisplatin S-1 bile duct cancer |
Additional relevant MeSH terms:
|
Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Biliary Tract Diseases Digestive System Diseases Gemcitabine Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013