Biliary Tract CancerPhase 1NCT01291615
Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
A Phase 1 study testing Gemcitabine and S-1 in people with Biliary Tract Cancer, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
Trial summary
To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Gemcitabine and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to May 2013
- Phase
- Phase 1
- 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
- Biliary tract cancer (>= UICC Stage IB)
- R0 or R1 resection due to biliary tract cancer (BTC)
- ECOG performance status must be 0 or 1
- The patient underwent no other treatment than surgery for BTC
- Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must be less than five times the normal limit, total bilirubin must be less than three times the normal limit, and creatinin must be less than 1.2 mg/dl.
- The patient can intake drugs per os.
- From 4 to 12 weeks after the surgery
- Written informed consent
Who cannot join
- Existence of active double cancer
- The patient suffered from severe drug allergy
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Any active infections exist.
- Pregnancy
- Severe mental disorder
- Others
Trial locations and contacts
1 site in 1 country.
About this study
To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy
Read the detailed description
There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more safety adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using continual reassessment method analysis. In this study, we decided that tolerable ratio of dose-limiting toxicity would be less than 10%.
- Conditions
- Biliary Tract Cancer
- Being tested
- Gemcitabine, S-1
- 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.
GemcitabineDrug
Also called gemzer
800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks
S-1Drug
Also called TS-1
S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine group | Experimental | 800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks Receives: Drug: Gemcitabine |
| S-1 group | Experimental | S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency in adverse events
The purpose of this study is to decide maximum tolerated dose and recommended dose. Recommended dose is a dose which would induce dose-limiting toxicity in 10% of participants. This will be calculated by continual reassessment method.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completionMay 2013
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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansai Hepatobiliary Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hiroaki Nagano, MD, PhD, Study director, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291615
- Sponsor's protocol ID
- KHBO1003
- Other IDs
- UMIN000004682
- Status last verified
- Oct 2014
- First submitted
- 3 Jan 2011
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kobayashi S, Nagano H, Sakai D, Eguchi H, Hatano E, Kanai M, Seo S, Taura K, Fujiwara Y, Ajiki T, Takemura S, Kubo S, Yanagimoto H, Toyokawa H, Tsuji A, Terajima H, Morita S, Ioka T. Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study. Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709. doi: 10.1007/s00280-014-2543-4. Epub 2014 Jul 30.
PubMed 25074036
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT01291615
- Acronym / sponsor ID
- KHBO1003
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kansai Hepatobiliary Oncology GroupResearch network
- Study start
- Dec 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Feb 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 decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy
Detailed description
There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more safety adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using continual reassessment method analysis. In this study, we decided that tolerable ratio of dose-limiting toxicity would be less than 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine group | Experimental | Drug: Gemcitabine800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks |
| S-1 group | Experimental | Drug: S-1S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biliary tract cancer (>= UICC Stage IB)
- R0 or R1 resection due to biliary tract cancer (BTC)
- ECOG performance status must be 0 or 1
- The patient underwent no other treatment than surgery for BTC
- Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must be less than five times the normal limit, total bilirubin must be less than three times the normal limit, and creatinin must be less than 1.2 mg/dl.
Key exclusion criteria (7 listed)
- Existence of active double cancer
- The patient suffered from severe drug allergy
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Any active infections exist.
- Pregnancy
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 |
|---|---|---|
| GemcitabineAlso: gemzer800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks | Drug | Gemcitabine group |
| S-1Also: TS-1S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks. | Drug | S-1 group |
Primary outcome
frequency in adverse events
Time frame: up to 12 weeks
The purpose of this study is to decide maximum tolerated dose and recommended dose. Recommended dose is a dose which would induce dose-limiting toxicity in 10% of participants. This will be calculated by continual reassessment method.
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 23 Oct 2014.
- Background: PubMed 25074036Kobayashi S, Nagano H, Sakai D, Eguchi H, Hatano E, Kanai M, Seo S, Taura K, Fujiwara Y, Ajiki T, Takemura S, Kubo S, Yanagimoto H, Toyokawa H, Tsuji A, Terajima H, Morita S, Ioka T. Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study. Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709. doi: 10.1007/s00280-014-2543-4. Epub 2014 Jul 30.
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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.
Hiroaki Nagano, MD, PhD study director
Osaka University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine and S-1 in people with Biliary Tract Cancer, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
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 8 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 23 Oct 2014. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
frequency in adverse events (time frame: up to 12 weeks). 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 NCT01291615, 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 23 Oct 2014.