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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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
Jarin Chindaprasirt
Khon Kaen, Thailand
RECRUITINGThe rate of overall response evaluated by MRI or CT
The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria
Time frame: Up to 15 weeks
Resectability rate
The rate of patients who can successfully undergo surgery after chemotherapy
Time frame: Up to 24 weeks
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
Time frame: every 15 days for approximately 24 weeks
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