Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Brief Title

Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Official Title

Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

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.
    

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

The rate of overall response evaluated by MRI or CT

Secondary Outcome

 Resectability rate

Condition

Cholangiocarcinoma

Intervention

mFOLFOXIRI

Study Arms / Comparison Groups

 mFOLFOXIRI

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

25

Start Date

September 19, 2018

Completion Date

December 2023

Primary Completion Date

August 2023

Eligibility 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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jarin Chindaprasirt, MD, 6643366562, [email protected]

Location Countries

Thailand

Location Countries

Thailand

NCT ID

NCT03603834

Organization ID

HE611336

Responsible Party

Principal Investigator

Study Sponsor

Khon Kaen University

Study Sponsor

Jarin Chindaprasirt, MD, Principal Investigator, Khon Kaen University

Verification Date

August 2021