Metastatic Biliary Tract CancerPhase 2NCT01096745
Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer
A Phase 2 study testing Gemcitabine, Cisplatin and S-1, Cisplatin in people with Metastatic Biliary Tract Cancer and Locally Advanced Biliary Tract Cancer, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Biliary Tract Cancer, Locally Advanced Biliary Tract Cancer
- What is being tested?
- Gemcitabine, Cisplatin and S-1, Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Sep 2013
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gyeongsang University Hospital
Jinju, Gyeongsangnam-do, 660-702
About this study
Official title: Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
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.
Read the 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.
- Being tested
- Gemcitabine, Cisplatin, S-1, Cisplatin
- Keywords
- Gemcitabine, Cisplatin, S-1, bile duct cancer
- Medical subject headings
- Biliary Tract Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, CisplatinDrug
Also called Gemcitabine - Gemcitane, Cisplatin - Cispulan
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
S-1, CisplatinDrug
Also called S-1; TS-1, Cisplatin ; Cispulan
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Cisplatin | Experimental | Not described Receives: Drug: Gemcitabine, Cisplatin |
| S-1/Cisplatin | Experimental | D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks Receives: Drug: S-1, Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: 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
Secondary outcomes (1)
Response rate Overall survival Safety profile
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2013 (estimated)
- Study completionSep 2013 (estimated)
Why it stopped: Planning for randomized phase III trial for this issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Dong-A University, Chung-Ang University
- Investigators
- Hyuk-Chan Kwon, M.D., Principal investigator, Dong-A University HospitalJung Hun Kang, M.D., Study director, Gyeongsang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096745
- Sponsor's protocol ID
- GNUHIRB-2010-5
- Status last verified
- Jun 2011
- First submitted
- 30 Mar 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No