Biliary Tract NeoplasmPhase 2NCT02527824
Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer
A Phase 2 study testing Oxaliplatin, Irinotecan, S-1 in people with Biliary Tract Neoplasm, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Tract Neoplasm
- What is being tested?
- Oxaliplatin, Irinotecan, S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Sep 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- More than 3 months expected life span
- Measurable lesion by RECIST criteria version 1.1
- Palliative chemotherapy naive
- Adequate organ functions
- Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Who cannot join
- Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
- Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
- Participants who had received major surgery 4 weeks before study enrollment
- Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
- Participants with central nervous system(CNS) metastases
- Participants with peripheral sensory neuropathies with impaired functional activities
- Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.
Read the detailed description
It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.
S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.
- Conditions
- Biliary Tract Neoplasm
- Being tested
- Oxaliplatin, Irinotecan, S-1
- Keywords
- biliary tract neoplasm, oxaliplatin, irinotecan, 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.
Oxaliplatin, Irinotecan, S-1Drug
Also called Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)
Treatment will be delivered every 2 weeks
- Oxaliplatin 65 mg/m2 iv on day 1
- Irinotecan 135 mg/m2 iv on day 1
- S-1 80 mg/m2/day on day1-7
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin, Irinotecan, S-1(OIS) | Experimental | intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle.
1. Oxaliplatin 65 mg/m2 iv on day 1
2. Irinotecan 135 mg/m2 iv on day 1
3. S-1 80 mg/m2/day on day 1-7 Receives: Drug: Oxaliplatin, Irinotecan, S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
Measured: 1.5 year
Secondary outcomes (3)
progression free survival
The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause
Measured: 1.5 year
overall survival
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
Measured: 1.5 year
toxicity profiles - the number of participants and grade of intensity of treatment related adverse events
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Dae Young Zang, MD, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527824
- Sponsor's protocol ID
- HMC-HO-GI-1501
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2015
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT02527824
- Acronym / sponsor ID
- HMC-HO-GI-1501
- Conditions
- Biliary Tract Neoplasm
- Keywords
- biliary tract neoplasm, oxaliplatin, irinotecan, S-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 19 Aug 2015 (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.
This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.
Detailed description
It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.
S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin, Irinotecan, S-1(OIS) | Experimental | Drug: Oxaliplatin, Irinotecan, S-1intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle. 1. Oxaliplatin 65 mg/m2 iv on day 1 2. Irinotecan 135 mg/m2 iv on day 1 3. S-1 80 mg/m2/day on day 1-7 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- More than 3 months expected life span
- Measurable lesion by RECIST criteria version 1.1
- Palliative chemotherapy naive
Key exclusion criteria (7 listed)
- Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
- Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
- Participants who had received major surgery 4 weeks before study enrollment
- Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
- Participants with central nervous system(CNS) metastases
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 |
|---|---|---|
| Oxaliplatin, Irinotecan, S-1Also: Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)Treatment will be delivered every 2 weeks 1. Oxaliplatin 65 mg/m2 iv on day 1 2. Irinotecan 135 mg/m2 iv on day 1 3. S-1 80 mg/m2/day on day1-7 | Drug | Oxaliplatin, Irinotecan, S-1(OIS) |
Primary outcome
overall response rate
Time frame: 1.5 year
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
3 secondary outcomes
progression free survival
Time frame: 1.5 year
overall survival
Time frame: 1.5 year
toxicity profiles - the number of participants and grade of intensity of treatment related adverse events
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Biliary Tract Neoplasm
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
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.
Dae Young Zang, MD, PhD principal investigator
Hallym University 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 Oxaliplatin, Irinotecan, S-1 in people with Biliary Tract Neoplasm, run by Hallym University 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 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 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 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?
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?
overall response rate (time frame: 1.5 year). 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 Aug 2017.