Biliary Tract CancerPhase 2NCT01917617
Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer
A Phase 2 study testing Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS) and Gemcitabine , Cisplatin in people with Biliary Tract Cancer, run by Kansai Hepatobiliary Oncology Group at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin. 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, Oral Rehydration Solution (ORS) and Gemcitabine , Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 22 May 2013to 7 Jul 2016
- 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
Inclusion Criteria: 1. Patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously 2. Patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks 3. Older than 20 years old 4. Eastern Cooperative Oncology Group Performance status of 0 or 1 5. Adequate main organ function 6. Fully oral intake ability to drink 500ml of solution before chemotherapy 7. Estimated life expectancy no less than 3 months 8. Written informed consent
- Exclusion Criteria: 1. Patients who received cisplatin previously 2. Radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia 3. Patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months 4. Patients with serious infection 5. Pregnant or lactating female or patients who wish pregnant 6. Patients having severe allergy 7. Patients with other serious comorbid diseases 8. Patients with severe psychological disease 9. Patients with uncontrollable watery diarrhea 10. Patients with moderate or severe ascites /pleural effusion 11. Patients with severe psychological disease 12. Patients who are positive for a test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir 13. Patients who is judged as an inappropriate case by the investigator
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer
The objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin.
Read the detailed description
A large amount of fluid infusion is required to load for the prevention of renal dysfunction by Cisplatin in combination of GC therapy. There is a problem infusion time is take a long time for this. In many institutions in Japan, GC therapy is performed over 3 hours or more, longer than original method in the ABC-002 trial. Oral rehydration therapy is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. Oral rehydration therapy (ORT) is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. Many reports suggest ORT may substitute for infusion therapy. Herein, the investigators planned the study to examine the safety of replacing the fluid infusion by oral rehydration expecting to shorten the time to drip.
- Conditions
- Biliary Tract Cancer
- Being tested
- Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS), 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 , Cisplatin, Oral Rehydration Solution (ORS)Drug
Also called Gemcitabine； gemzer, Cisplatin；Cispulan, Oral Rehydration Solution(ORS)；OS-1
Short hydration via oral rehydration solution (OS-1)
Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively.
Gemcitabine , CisplatinDrug
Also called Gemcitabine； gemzer, Cisplatin； Cispulan
Standard hydration via intravenous infusion
Cisplatin plus gemcitabine will be administered via usual infusion regimen by each hospital. In general, it is administered total 2 litters over 3 hours or more.
| Study group | Role | What they receive |
|---|---|---|
| Oral rehydration group（Short Hydration） | Experimental | Gemcitabine； gemzer Cisplatin；Cispulan Oral Rehydration Solution(ORS)；OS-1
Short hydration via oral rehydration solution (OS-1)
Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively. Receives: Drug: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS) |
| Standard group（Long Hydration） | Active comparator | Drug: Gemcitabine , Cisplatin
Other Names:
Gemcitabine； gemzer Cisplatin； Cispulan
Standard hydration via intravenous infusion
Cisplatin plus gemcitabine will be administered via usual infusion regimen by each hospital. In general, it is administered total 2 litters over 3 hours or more. Receives: Drug: Gemcitabine , Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate during the 12 weeks in the short hydration group
Completion rate during the 12 weeks in the short hydration group is defined as percentage proportion of treatment complete cases for 12 weeks of the eligible cases. Treatment completion is defined as carrying out a short hydration regimen via ORT.
Measured: 12 weeks
Secondary outcomes (7)
Rate of renal toxicity
Measured: 12 weeks
Adverse events
Measured: 12 weeks
Marker of renal function
Measured: 12 weeks
Response rate
Measured: 12 weeks
Time to treatment failure
Measured: 6 months
Progression free survival
Measured: 6 months
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study start22 May 2013
- Primary completion7 Jan 2016
- Study completion7 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT01917617
- Sponsor's protocol ID
- KHBO1302
- Other IDs
- UMIN000010695
- Status last verified
- May 2017
- First submitted
- 4 Aug 2013
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT01917617
- Acronym / sponsor ID
- KHBO1302
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kansai Hepatobiliary Oncology GroupResearch network
- Study start
- 22 May 2013 (actual)
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 7 Jul 2016 (actual)
- First posted
- 6 Aug 2013 (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 objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin.
Detailed description
A large amount of fluid infusion is required to load for the prevention of renal dysfunction by Cisplatin in combination of GC therapy. There is a problem infusion time is take a long time for this. In many institutions in Japan, GC therapy is performed over 3 hours or more, longer than original method in the ABC-002 trial. Oral rehydration therapy is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. Oral rehydration therapy (ORT) is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. Many reports suggest ORT may substitute for infusion therapy. Herein, the investigators planned the study to examine the safety of replacing the fluid infusion by oral rehydration expecting to shorten the time to drip.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral rehydration group（Short Hydration） | Experimental | Drug: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS)Gemcitabine； gemzer Cisplatin；Cispulan Oral Rehydration Solution(ORS)；OS-1 Short hydration via oral rehydration solution (OS-1) Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively. |
| Standard group（Long Hydration） | Active comparator | Drug: Gemcitabine , CisplatinDrug: Gemcitabine , Cisplatin Other Names: Gemcitabine； gemzer Cisplatin； Cispulan Standard hydration via intravenous infusion Cisplatin plus gemcitabine will be administered via usual infusion regimen by each hospital. In general, it is administered total 2 litters over 3 hours or more. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 , Cisplatin, Oral Rehydration Solution (ORS)Also: Gemcitabine； gemzer, Cisplatin；Cispulan, Oral Rehydration Solution(ORS)；OS-1Short hydration via oral rehydration solution (OS-1) Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively. | Drug | Oral rehydration group（Short Hydration） |
| Gemcitabine , CisplatinAlso: Gemcitabine； gemzer, Cisplatin； CispulanStandard hydration via intravenous infusion Cisplatin plus gemcitabine will be administered via usual infusion regimen by each hospital. In general, it is administered total 2 litters over 3 hours or more. | Drug | Standard group（Long Hydration） |
Primary outcome
Completion rate during the 12 weeks in the short hydration group
Time frame: 12 weeks
Completion rate during the 12 weeks in the short hydration group is defined as percentage proportion of treatment complete cases for 12 weeks of the eligible cases. Treatment completion is defined as carrying out a short hydration regimen via ORT.
7 secondary outcomes
Rate of renal toxicity
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Marker of renal function
Time frame: 12 weeks
Response rate
Time frame: 12 weeks
Time to treatment failure
Time frame: 6 months
Progression free survival
Time frame: 6 months
Overall survival
Time frame: 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 21 Feb 2019.
Related trials for Biliary Tract Cancer
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.
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 2 study testing Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS) and 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?
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 21 Feb 2019. 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 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?
Completion rate during the 12 weeks in the short hydration group (time frame: 12 weeks). 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 21 Feb 2019.