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Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status

Recruiting

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

mFOLFOXIRI

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Neoadjuvant, Potentially resectable, Chemotherapy, Bile duct cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jarin ChindaprasirtRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mFOLFOXIRI

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Resectability rate

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

Full Information

NCT ID

NCT03603834

First Posted

July 17, 2018

Last Updated

August 31, 2021

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT03603834

Brief Title

Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Official Title

Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 19, 2018 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma

Keywords

Neoadjuvant, Potentially resectable, Chemotherapy, Bile duct cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mFOLFOXIRI

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

mFOLFOXIRI

Other Intervention Name(s)

Oxaliplatin, Irinotecan, Fluorouracil, Leucovorin

Intervention Description

Primary Outcome Measure Information:

Title

The rate of overall response evaluated by MRI or CT

Description

The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria

Time Frame

Up to 15 weeks

Secondary Outcome Measure Information:

Title

Resectability rate

Description

The rate of patients who can successfully undergo surgery after chemotherapy

Time Frame

Up to 24 weeks

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

every 15 days for approximately 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jarin Chindaprasirt, MD

Phone

6643366562

jarich@kku.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Jaruda Sringam, Master

Phone

6643366562

talnurse8@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jarin Chindaprasirt, MD

Organizational Affiliation

Khon Kaen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jarin Chindaprasirt

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jureerat Ratanaphet, Master

Phone

6643366592

jurepr@kku.ac.th

First Name & Middle Initial & Last Name & Degree

Jarin Chindaprasirt, MD

First Name & Middle Initial & Last Name & Degree

Aumkhae Sookprasert, MD

First Name & Middle Initial & Last Name & Degree

Kosin Wirasorn, MD

First Name & Middle Initial & Last Name & Degree

Attapol Titapun, MD

First Name & Middle Initial & Last Name & Degree

Kulyada Somsap, MD

First Name & Middle Initial & Last Name & Degree

Watcharin Loilome, MD

First Name & Middle Initial & Last Name & Degree

Narong Kuntikheo, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

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