A randomized phase II study comparing liposomal irinotecan + fluorouracil + levofolinate to FOLFIRINOX as second-line chemotherapy for pancreatic cancer (NUPAT-09 trial)

JRCT ID: jRCT1041200082

Registered date:24/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 24/12/2020
• Target sample size: 40
• Study type: Interventional

Intervention(s)

1. FF+nal-IRI arm
Irinotecan liposome formulation (70 mg/m2 as irinotecan), levofolinate 200 mg/m2, fluorouracil 2400 mg/m2 for 46 hours, every 2 weeks.
2. FOLFIRINOX arm
Oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, levofolinate 200 mg/m2, fluorouracil 400 mg/m2 as a bolus, fluorouracil 2,400 mg/m2 as 46-hour continuous infusion, every 2 weeks.

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression free survival, time to treatment failure and response rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Advanced or recurrent pancreatic cancer treated with primary chemotherapy including gemcitabine
2. ECOG performance status 0 or 1
3. Neutrophil count >= 2,000/mm3
4. Platelet count >= 100,000/mm3
5. Total bilirubin >= upper limit of normal x 1.5

Exclude criteria

1. Complications of infectious diseases
2. Serious cardiac disease or a history of such disease
3. Intestinal paralysis or intestinal obstruction
4. Interstitial pneumonia or pulmonary fibrosis
5. Massive ascites or pleural effusions
6. Severe dysesthesia or sensory deficiency with functional impairment
7. A history of hypersensitivity to oxaliplatin or other platinum-containing drugs, irinotecan, liposomal irinotecan, fluorouracil, or levofolinate.
8. Pregnant women or women who may be pregnant
9. Patients on atazanavir sulfate

Related Information

• Primary Sponsor: Maeda Osamu