Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

NCT ID: NCT03603834

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2023-12-31

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.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

mFOLFOXIRI

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin; Irinotecan; Fluorouracil; Leucovorin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Jarin Chindaprasirt

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jarin Chindaprasirt, MD

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Jarin Chindaprasirt

Khon Kaen, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Jarin Chindaprasirt, MD

Role: CONTACT

jarich@kku.ac.th

6643366562

Jaruda Sringam, Master

Role: CONTACT

talnurse8@gmail.com

6643366562

Facility Contacts

Jureerat Ratanaphet, Master

Role: primary

jurepr@kku.ac.th

6643366592

Other Identifiers

HE611336

Identifier Type: -

Identifier Source: org_study_id