Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

NCT03603834 | Unknown Phase 2

• 1 other identifier: HE611336
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Neoadjuvant; Potentially resectable; Chemotherapy; Bile duct cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Resectability rate

  Up to 24 weeks

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

  every 15 days for approximately 24 weeks

Study Arms (1)

mFOLFOXIRI

EXPERIMENTAL

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

Interventions

mFOLFOXIRI 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

Also known as: Oxaliplatin, Irinotecan, Fluorouracil, Leucovorin

mFOLFOXIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Jarin Chindaprasirt

Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Bile Duct Neoplasms

Interventions

Oxaliplatin; Irinotecan; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jarin Chindaprasirt, MD

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarin Chindaprasirt, MD

CONTACT

6643366562; jarich@kku.ac.th

Jaruda Sringam, Master

CONTACT

6643366562; talnurse8@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 27, 2018
• Study Start: September 19, 2018
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)