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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
- ClinicalTrials.gov ID
- NCT01096745
- Acronym / sponsor ID
- GNUHIRB-2010-5
- Keywords
- Gemcitabine, Cisplatin, S-1, bile duct cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planning for randomized phase III trial for this issue.
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Dong-A University, Chung-Ang University
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Cisplatin | Experimental | Drug: Gemcitabine, Cisplatin |
| S-1/Cisplatin | Experimental | Drug: S-1, CisplatinD1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine, CisplatinAlso: Gemcitabine - Gemcitane, Cisplatin - CispulanD1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks | Drug | Gemcitabine/Cisplatin |
| S-1, CisplatinAlso: S-1; TS-1, Cisplatin ; CispulanD1-14 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 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Planning for randomized phase III trial for this issue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyuk-Chan Kwon, M.D. principal investigator
Dong-A University Hospital
Jung Hun Kang, M.D. study director
Gyeongsang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Planning for randomized phase III trial for this issue.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.