Neoadjuvant FOLFIRINOX

JRCT ID: jRCT1041220027

Registered date:04/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 12/07/2022
• Target sample size: 72
• Study type: Interventional

Intervention(s)

The following regimens are administered for one course of 2 weeks
Original FOLFIRINOX regimen (Age younger than 70) oxaliplatin 85mg/m2 (day1), leucovorin 200mg/m2 (day1), irinotecan 180mg/m2 (day1), bolus 5-FU 400mg/m2 (day1), continuous 5-FU 2,400m/m2 (day1-3)
modified FOLFIRINOX regimen (Age 70 or older) oxaliplatin 85mg/m2 (day1), leucovorin 200mg/m2 (day1), irinotecan 150mg/m2 (day1), continuous 5-FU 2,400m/m2 (day1-3)

Outcome(s)

• Primary Outcome: R0 resection rate
• Secondary Outcome: resection rate, pathological response, adverse event, completion rate, relative dose intensity, progression-free survival, 2-year survival, overall survival, subsequent therapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both
• Include criteria: Pathologically diagnosed as pancreatic adenocarcinoma or adenosquamous carcinoma; diagnosed as resectable or borderline resectable (BR-PV) (cohort1) or borderline resectable (BR-A); 20-80 years or older; ECOG Performance status 0 or 1; preservation of major organ function; written informed consent
• Exclude criteria: double cancer; severe infection; refractory ascites or pleural effusion; pregnant or lactating women, or women of childbearing potential; metastases to central nervous system; mental disorder; severe complication; patients who investigator regards as inappropriate for candidate

Related Information

• Primary Sponsor: Yamashita Taro