Neoadjuvant FOLFIRINOX for borderline or locally advanced pancreatic cancer

JRCT ID: jRCT1051190099

Registered date:28/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic ductal adenocarcinoma
• Date of first enrollment: 19/06/2020
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Neoadjuvant FOLFIRINOX followed by curative resection

Outcome(s)

• Primary Outcome: R0 resectability

Secondary Outcome

- Pancreatic resection
- Relative dose intensity
- Radiographically response rate
- Overall Survival
- Distant recurrence-free survival
- Disease-free survival
- Completion rate for 6 courses of FOLFIRINOX

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Histologically diagnosed pancreatic ducatal adenocarcinoma: including suspected case of adenocarcinoma by a cytology.
- Anable to undergo dynamic computed tomography.
- Radiologically diagnosed borderline resectable or locally advanced unresectable pancreatic ductal adenocarcinoma according to NCCN guideline 2018.
- Age 20 - 75
- ECOG performance status 0 or 1
- No treatment history for pancreatic ductal adenocarcinoma.
- No more than grade 1 peripheral sensory and motor neuropathy.
- Good functional capacities of main organs within two weekes before enrollment.
- Expected survival time more than 3 months.
- Feasible for pancreatic resection.
- With imformed written consent.

Exclude criteria

- Homozygous or double heterozygous fot UGT1A1*28, 6.
- Bleeding disorders
- Administration of steroid or immunosuppressive drug
- Severe complication of main organs
- Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- Uncontrollable infectious disease
- Uncontrollable diarrhea
- Pregnancy
- Double cancer with disease-free survival less than 5 years: excluding cured cutaneous basal cell cancer and gastrointestinal cancer with endoscopically curative resection.
- Investigator judgement that the patient should not participate for any reason

Related Information

• Primary Sponsor: Toyama Hirochika