Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Sponsor

Khon Kaen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03603834

Collaborator

(none)

Enrollment

Location

Arm

62.4

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

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 :

Sep 19, 2018

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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: 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 Other Names: Oxaliplatin Irinotecan Fluorouracil Leucovorin

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

Other Names:

Oxaliplatin

Irinotecan

Fluorouracil

Leucovorin

Outcome Measures

Primary Outcome Measures

The rate of overall response evaluated by MRI or CT [Up to 15 weeks]
The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria

Secondary Outcome Measures

Resectability rate [Up to 24 weeks]
The rate of patients who can successfully undergo surgery after chemotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [every 15 days for approximately 24 weeks]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 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:

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.

Exclusion Criteria:

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.
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.