Clinical trial NCT03603834: Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
Official title: Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: Neoadjuvant
Potentially resectable
Chemotherapy
Bile duct cancer
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of overall response evaluated by MRI or CT
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Resectability rate
timeFrame: Up to 24 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: every 15 days for approximately 24 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Jarin Chindaprasirt
Study officials:
affiliation: Khon Kaen University
name: Jarin Chindaprasirt, MD
role: PRINCIPAL_INVESTIGATOR
References: