Cholangiocarcinoma
Conditions
Keywords
Neoadjuvant, Potentially resectable, Chemotherapy, Bile duct cancer
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.
Interventions
DRUGmFOLFOXIRI
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
Khon Kaen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of overall response evaluated by MRI or CT | Up to 15 weeks | The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resectability rate | Up to 24 weeks | The rate of patients who can successfully undergo surgery after chemotherapy |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | every 15 days for approximately 24 weeks | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
Thailand
Contacts
Primary ContactJarin Chindaprasirt, MD
Backup ContactJaruda Sringam, Master
Outcome results
None listed