CholangiocarcinomaPhase 2NCT03603834
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
A Phase 2 study testing mFOLFOXIRI in people with Cholangiocarcinoma, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- mFOLFOXIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- 19 Sep 2018to Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old at the time of informed consent
- Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- No distant metastasis
- The disease is either resectable or potentially resectable
- Patients must have adequate organ function as defined by the following laboratory values at study entry:
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- Hemoglobin ≥ 8 g/dL (transfusions are acceptable) ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L AST/ALT ≤ 3 x ULN Total bilirubin ≤ 2.5 mg/dL Creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
- Women of childbearing potential definition (WOCBP) and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 3 months after the end of treatment.
- WOCBP must have a negative serum or urine pregnancy test prior to initiation of treatment.
Who cannot join
- > 75 years old
- Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy
- Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.
- Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
- Pregnant or lactating women.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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- Liver disease including but not limited to cirrhosis, primary sclerosing cholangitis, future liver remnant of less than 20-30%
- Comorbidity including but not limited to active clinically serious infections, congestive heart failure, life-threatening arrhythmia
- known HIV positive
- Baseline peripheral neuropathy/paresthesia grade ≥ 2.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Jarin Chindaprasirt
Khon Kaen, 40002
Jureerat Ratanaphet, Master, 6643366592, jurepr@kku.ac.th
Jarin Chindaprasirt, MD
About this study
Official title: Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.
Read the detailed description
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma.
This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.
This phase 2 trial was designed to enroll 25 patients with BRCC who were assigned to mFOLFOXIRI neoadjuvant chemotherapy. The primary endpoint was the overall response rate.
- Conditions
- Cholangiocarcinoma
- Being tested
- mFOLFOXIRI
- Keywords
- Neoadjuvant, Potentially resectable, Chemotherapy, Bile duct cancer
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOXIRIDrug
Also called Oxaliplatin, Irinotecan, Fluorouracil, Leucovorin
mFOLFOXIRI consists of the following combination of drugs:
- Oxaliplatin, 85 mg/m2, IV over 2 hours
- Leucovorin, 400 mg/m2, IV over 2 hours
- Irinotecan, 150 mg/m2, IV over 90 minutes
- 5 FU, 400 mg/m2, IV bolus
- 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection each 14 day cycle, for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOXIRI | Experimental | mFOLFOXIRI consists of the following combination of drugs:
Oxaliplatin, 85 mg/m2, IV over 2 hours Leucovorin, 400 mg/m2, IV over 2 hours Irinotecan, 150 mg/m2, IV over 90 minutes 5 FU, 400 mg/m2, IV bolus 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection
each 14 day cycle, for 6 cycles Receives: Drug: mFOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of overall response evaluated by MRI or CT
The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria
Measured: Up to 15 weeks
Secondary outcomes (2)
Resectability rate
The rate of patients who can successfully undergo surgery after chemotherapy
Measured: Up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: every 15 days for approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start19 Sep 2018
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarin Chindaprasirt, Khon Kaen University
- Investigators
- Jarin Chindaprasirt, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603834
- Sponsor's protocol ID
- HE611336
- Status last verified
- Aug 2021
- First submitted
- 17 Jul 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT03603834
- Acronym / sponsor ID
- HE611336
- Conditions
- Cholangiocarcinoma
- Keywords
- Neoadjuvant, Potentially resectable, Chemotherapy, Bile duct cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jul 2018 (actual)
- 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.
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.
Detailed description
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma.
This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.
This phase 2 trial was designed to enroll 25 patients with BRCC who were assigned to mFOLFOXIRI neoadjuvant chemotherapy. The primary endpoint was the overall response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOXIRI | Experimental | Drug: mFOLFOXIRImFOLFOXIRI consists of the following combination of drugs: Oxaliplatin, 85 mg/m2, IV over 2 hours Leucovorin, 400 mg/m2, IV over 2 hours Irinotecan, 150 mg/m2, IV over 90 minutes 5 FU, 400 mg/m2, IV bolus 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection each 14 day cycle, for 6 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18 years old at the time of informed consent
- Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- No distant metastasis
- The disease is either resectable or potentially resectable
Key exclusion criteria (10 listed)
- > 75 years old
- Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy
- Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.
- Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
- Pregnant or lactating women.
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 |
|---|---|---|
| mFOLFOXIRIAlso: Oxaliplatin, Irinotecan, Fluorouracil, LeucovorinmFOLFOXIRI consists of the following combination of drugs: 1. Oxaliplatin, 85 mg/m2, IV over 2 hours 2. Leucovorin, 400 mg/m2, IV over 2 hours 3. Irinotecan, 150 mg/m2, IV over 90 minutes 4. 5 FU, 400 mg/m2, IV bolus 5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection each 14 day cycle, for 6 cycles | Drug | mFOLFOXIRI |
Primary outcome
The rate of overall response evaluated by MRI or CT
Time frame: Up to 15 weeks
The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria
2 secondary outcomes
Resectability rate
Time frame: Up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: every 15 days for approximately 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Jarin Chindaprasirt, MD principal investigator
Khon Kaen University
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 mFOLFOXIRI in people with Cholangiocarcinoma, run by Khon Kaen University at 1 site in Thailand.
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 10 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 1 Sep 2021. 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 Thailand. 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?
Contact Jarin Chindaprasirt, MD (6643366562, jarich@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of overall response evaluated by MRI or CT (time frame: Up to 15 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 1 Sep 2021.