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Neoadjuvant FOLFIRINOX for borderline or locally advanced pancreatic cancer

A phase II study of neoadjuvant FOLFIRINOX in patients with borderline or locally advanced unresectable pancreatic ductal adenocarcinoma. - NAT FFX for BR or UR-LA PDAC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051190099
Enrollment
25
Registered
2020-01-28
Start date
2020-06-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma pancreatic ductal adenocarcinoma, pancreatic cancer, borderline resectable pancreatic cancer, locally advanced pancreatic cancer

Interventions

Neoadjuvant FOLFIRINOX followed by curative resection
neoadjuvant therapy, FOLFIRINOX, GCSF

Sponsors

Toyama Hirochika
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
R0 resectability

Secondary

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

Contacts

Public ContactHirochika Toyama

Kobe University Hospital

toyama@med.kobe-u.ac.jp+81-78-382-6302

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026