Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03603834
• Other study ID #: HE611336
• Status: Recruiting
• Phase: Phase 2
• Start date: September 19, 2018
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Khon Kaen University
• Contact: Jarin Chindaprasirt, MD
• Phone: 6643366562
• Email: jarich[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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

Locations

Country	Name	City	State
Thailand	Jarin Chindaprasirt	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 15 weeks
Secondary	Resectability rate	The rate of patients who can successfully undergo surgery after chemotherapy	Up to 24 weeks
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	every 15 days for approximately 24 weeks