Biliary Tract CancerPhase 1NCT01297998
A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy
A Phase 1 study testing gemcitabine , cisplatin 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 recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy. 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 , cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2011to Jun 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 (BTC) with more than stage IB
- BTC undergoing R0 or R1 resection without major hepatectomy
- Older than 20 years old
- PS0 or 1
- No treatment other than surgery
- No dysfunction of main organs
Show all 9Show fewer
- Possible oral intake
- Treatment start; after 4 weeks and within 12 weeks after surgery
- Obtained written informed consent
Who cannot join
- Patients with resection of major hepatectomy
- Patients with double cancers
- Patients having severe allergy
- Patients with severe organ dysfunction
- Patients with active infectious disease
- Pregnancy
- Patients with severe psychological disease
- Patients seem inadequate for this study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.
Read the detailed description
Surgery currently remains the only potentially curative treatment for biliary tract cancer (BTC), and most patients develop recurrence. Therefore, effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients. However, to date, no standard adjuvant chemotherapy has been established, and a guideline for BTC treatment recommends that trials of adjuvant chemotherapy be carried out.
Based on results from clinical studies in unresectable BTC, gemcitabine, platinum agent, fluoropyrimidine are considered to have activity against BTC. These agents are expected to be effective in the postoperative adjuvant therapy for BTC, Thus, randomized controlled trials with gemcitabine are ongoing, and the results are expected. Recently, in the ABC-02 study, the first prospective multicenter phase III study in patients with unresectable BTC, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST (from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for unresectable BTC, and we expect this regimen to be effective for postoperative adjuvant therapy.
Though hepatectomy is frequently performed in surgery for BTC, it is unclear that the effect of anticancer agent is affected by hepatectomy. Because gemcitabine is metabolized by cytidine deaminase primarily in the liver, it considered to have decreased the metabolic ability of gemcitabine after hepatectomy. Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine. In the adjuvant chemotherapy with gemcitabine, it is necessary to examine separately whether hepatectomy was undergone or not.
In this study, we aimed to assess the safety and efficacy of gemcitabine/cisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy.
- Conditions
- Biliary Tract Cancer
- Being tested
- 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.
gemcitabine , cisplatinDrug
Also called Gemcitabine;gemzer,Cisplatin;Cispulan
Dose of gemcitabine and cisplatin and treatment schedule
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine , cisplatin | Experimental | Not described Receives: Drug: gemcitabine , cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Measured: Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1)
Secondary outcomes (1)
Number of Participants with dose limiting toxicity
Dose limiting toxicity is defined as follows
- Grade 4 neutropenia, thrombocytopenia
- Grade 3 or 4 febrile neutropenia
- Grade 3 or 4 non-hematological adverse events unless unresponsive to treatment
- Any adverse events resulting in interruption of dosing on day 8 in both the two courses
- Any adverse events resulting in dose modification or delay of longer than 2 week
Measured: At the end of adjuvant chemotherapy (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionJun 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansai Hepatobiliary Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tetsuo Ajiki, MD, PhD, Study director, Kobe University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297998
- Sponsor's protocol ID
- KHBO1004
- Other IDs
- UMIN000004622
- Status last verified
- Jun 2014
- First submitted
- 7 Feb 2011
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toyoda M, Ajiki T, Fujiwara Y, Nagano H, Kobayashi S, Sakai D, Hatano E, Kanai M, Nakamori S, Miyamoto A, Tsuji A, Kaihara S, Ikoma H, Takemura S, Toyokawa H, Terajima H, Morita S, Ioka T. Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1004). Cancer Chemother Pharmacol. 2014 Jun;73(6):1295-301. doi: 10.1007/s00280-014-2431-y. Epub 2014 Mar 11.
PubMed 24614947
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
- ClinicalTrials.gov ID
- NCT01297998
- Acronym / sponsor ID
- KHBO1004
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kansai Hepatobiliary Oncology GroupResearch network
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 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 recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.
Detailed description
Surgery currently remains the only potentially curative treatment for biliary tract cancer (BTC), and most patients develop recurrence. Therefore, effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients. However, to date, no standard adjuvant chemotherapy has been established, and a guideline for BTC treatment recommends that trials of adjuvant chemotherapy be carried out.
Based on results from clinical studies in unresectable BTC, gemcitabine, platinum agent, fluoropyrimidine are considered to have activity against BTC. These agents are expected to be effective in the postoperative adjuvant therapy for BTC, Thus, randomized controlled trials with gemcitabine are ongoing, and the results are expected. Recently, in the ABC-02 study, the first prospective multicenter phase III study in patients with unresectable BTC, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST (from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for unresectable BTC, and we expect this regimen to be effective for postoperative adjuvant therapy.
Though hepatectomy is frequently performed in surgery for BTC, it is unclear that the effect of anticancer agent is affected by hepatectomy. Because gemcitabine is metabolized by cytidine deaminase primarily in the liver, it considered to have decreased the metabolic ability of gemcitabine after hepatectomy. Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine. In the adjuvant chemotherapy with gemcitabine, it is necessary to examine separately whether hepatectomy was undergone or not.
In this study, we aimed to assess the safety and efficacy of gemcitabine/cisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine , cisplatin | Experimental | Drug: gemcitabine , cisplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biliary tract cancer (BTC) with more than stage IB
- BTC undergoing R0 or R1 resection without major hepatectomy
- Older than 20 years old
- PS0 or 1
- No treatment other than surgery
Key exclusion criteria (8 listed)
- Patients with resection of major hepatectomy
- Patients with double cancers
- Patients having severe allergy
- Patients with severe organ dysfunction
- Patients with active infectious disease
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;gemzer,Cisplatin;CispulanDose of gemcitabine and cisplatin and treatment schedule | Drug | gemcitabine , cisplatin |
Primary outcome
Maximum tolerated dose
Time frame: Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1)
To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
1 secondary outcome
Number of Participants with dose limiting toxicity
Time frame: At the end of adjuvant chemotherapy (6 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 17 Nov 2017.
- Derived from this study: PubMed 24614947Toyoda M, Ajiki T, Fujiwara Y, Nagano H, Kobayashi S, Sakai D, Hatano E, Kanai M, Nakamori S, Miyamoto A, Tsuji A, Kaihara S, Ikoma H, Takemura S, Toyokawa H, Terajima H, Morita S, Ioka T. Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1004). Cancer Chemother Pharmacol. 2014 Jun;73(6):1295-301. doi: 10.1007/s00280-014-2431-y. Epub 2014 Mar 11.
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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.
Tetsuo Ajiki, MD, PhD study director
Kobe 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 , cisplatin 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 9 inclusion and 8 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 17 Nov 2017. 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?
Maximum tolerated dose (time frame: Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1)). 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 NCT01297998, 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 17 Nov 2017.