Metastatic Biliary CancerPhase 2NCT01375972
Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma
A Phase 2 study testing S-1 plus cisplatin and Gemcitabine plus Cisplatin in people with Metastatic Biliary Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Biliary Cancer
- What is being tested?
- S-1 plus cisplatin and Gemcitabine plus Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven biliary adenocarinoma
- Age > 18
- Evaluable disease
- ECOG performance status of 2 or better
- No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
- Adequate bone marrow function A. WBCs > 4,000/µL, absolute neutrophil count [ANC]>1,500/µL B. Hemoglobin >9.0 g/dL C. Platelets > 100,000/µL
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- Adequate kidney function (creatinine<1.5 mg/dL)
- Adequate liver function (bilirubin<1.5 mg/dL [< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction], transaminases levels<3 times the upper normal limit, and serum albumin of >2.5 mg/dL)
- No serious medical or psychological condition that would preclude study treatment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- Other tumor type than adenocarcinoma
- Evidence of GI bleeding or GI obstruction
- Presence or history of CNS metastasis
- Pregnancy or breastfeeding
- Other serious illness or medical conditions
- Axial skeletal radiotherapy within 6 months
- Neuropathy grade 2 or worse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.
- Conditions
- Metastatic Biliary Cancer
- Being tested
- S-1 plus cisplatin, Gemcitabine plus Cisplatin
- Keywords
- biliary cancer, systemic chemotherapy, S-1, gemcitabine, cisplatin
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 plus cisplatinDrug
S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
Gemcitabine plus CisplatinDrug
Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| SP treatment | Experimental | S-1 plus cisplatin combination chemotherapy Receives: Drug: S-1 plus cisplatin |
| GP treatment | Active comparator | Gemcitabine plus Cisplatin combination chemotherapy Receives: Drug: Gemcitabine plus Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate at 6 months
progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.
Measured: 6 months
Secondary outcomes (3)
Response rate
Response to chemotherapy will be assessed using RECIST 1.0 criteria.
Measured: 6 months
Toxicities
Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described.
Measured: Up to 24 months
overall survival
Overall survival is calculated from the date of enrollment to the date of death from any cause.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Biliary CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JLee, Asan Medical Center
- Investigators
- MJ Kang, MD, MSc, Study director, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375972
- Sponsor's protocol ID
- AMC_0803
- Status last verified
- Dec 2011
- First submitted
- 15 Jun 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.
PubMed 22559158
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
- ClinicalTrials.gov ID
- NCT01375972
- Acronym / sponsor ID
- AMC_0803
- Conditions
- Metastatic Biliary Cancer
- Keywords
- biliary cancer, systemic chemotherapy, S-1, gemcitabine, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Jun 2011 (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.
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP treatment | Experimental | Drug: S-1 plus cisplatinS-1 plus cisplatin combination chemotherapy |
| GP treatment | Active comparator | Drug: Gemcitabine plus CisplatinGemcitabine plus Cisplatin combination chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically proven biliary adenocarinoma
- Age > 18
- Evaluable disease
- ECOG performance status of 2 or better
- No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
Key exclusion criteria (7 listed)
- Other tumor type than adenocarcinoma
- Evidence of GI bleeding or GI obstruction
- Presence or history of CNS metastasis
- Pregnancy or breastfeeding
- Other serious illness or medical conditions
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 |
|---|---|---|
| S-1 plus cisplatinS-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks | Drug | SP treatment |
| Gemcitabine plus CisplatinGemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks | Drug | GP treatment |
Primary outcome
Progression-free survival rate at 6 months
Time frame: 6 months
progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.
3 secondary outcomes
Response rate
Time frame: 6 months
Toxicities
Time frame: Up to 24 months
overall survival
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Derived from this study: PubMed 22559158Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.
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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.
MJ Kang, MD, MSc study director
Asan Medical Center
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 S-1 plus cisplatin and Gemcitabine plus Cisplatin in people with Metastatic Biliary Cancer, run by Asan Medical Center 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 6 Dec 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375972, which also lists 1 linked publication.
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 6 Dec 2011.