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Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT03603834
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jarin Chindaprasirt, Khon Kaen University

Brief 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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: mFOLFOXIRI Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mFOLFOXIRI

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

Drug: mFOLFOXIRI

mFOLFOXIRI 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

Other Names:
  • Oxaliplatin
  • Irinotecan
  • Fluorouracil
  • Leucovorin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Resectability rate [ Time Frame: Up to 24 weeks ]
    The rate of patients who can successfully undergo surgery after chemotherapy

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: every 15 days for approximately 24 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years old at the time of informed consent
  2. Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria
  3. ECOG performance status of 0 or 1
  4. No distant metastasis
  5. The disease is either resectable or potentially resectable
  6. Patients must have adequate organ function as defined by the following laboratory values at study entry:

    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)

  7. 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.
  8. WOCBP must have a negative serum or urine pregnancy test prior to initiation of treatment.

Exclusion Criteria:

  1. > 75 years old
  2. Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy
  3. Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.
  4. Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
  5. Pregnant or lactating women.
  6. 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.
  7. Liver disease including but not limited to cirrhosis, primary sclerosing cholangitis, future liver remnant of less than 20-30%
  8. Comorbidity including but not limited to active clinically serious infections, congestive heart failure, life-threatening arrhythmia
  9. known HIV positive
  10. Baseline peripheral neuropathy/paresthesia grade ≥ 2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603834


Contacts
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Contact: Jarin Chindaprasirt, MD 6643366562 jarich@kku.ac.th
Contact: Jaruda Sringam, Master 6643366562 talnurse8@gmail.com

Locations
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Thailand
Jarin Chindaprasirt Recruiting
Khon Kaen, Thailand, 40002
Contact: Jaruda Sringam, Master    6643366592    talnurse8@gmail.com   
Principal Investigator: Jarin Chindaprasirt, MD         
Sub-Investigator: Aumkhae Sookprasert, MD         
Sub-Investigator: Kosin Wirasorn, MD         
Sub-Investigator: Attapol Titapun, MD         
Sub-Investigator: Kulyada Somsap, MD         
Sub-Investigator: Watcharin Loilome, MD         
Sub-Investigator: Narong Kuntikheo, MD         
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Jarin Chindaprasirt, MD Khon Kaen University

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Responsible Party: Jarin Chindaprasirt, Assistant professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03603834     History of Changes
Other Study ID Numbers: HE611336
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jarin Chindaprasirt, Khon Kaen University:
Neoadjuvant
Potentially resectable
Chemotherapy
Bile duct cancer

Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action