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Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

NCT03603834 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-09-01

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Jarin Chindaprasirt, MD · Khon Kaen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2023-08-31
Completion
2023-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603834 on ClinicalTrials.gov