eoadjuvant FOLFIRINOX for borderline or locally advanced pancreatic cancer

Phase 2

Recruiting

• Conditions: Pancreatic ductal adenocarcinoma; pancreatic ductal adenocarcinoma, pancreatic cancer, borderline resectable pancreatic cancer, locally advanced pancreatic cancer; D021441

• Registration Number: JPRN-jRCT1051190099
• Lead Sponsor: Toyama Hirochika

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified