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Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

NCT06714604 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2024-12-03

No results posted yet for this study

Summary

The goal of this multicenter randomized controlled phase III trial is to compare two durations of neoadjuvant chemotherapy (NAT) with mFOLFIRINOX or gemcitabine-nab-paclitaxel (GnP) before attempt for surgical resection in patients with borderline (BR) and locally advanced pancreatic cancer (LAPC). Patients with histologically confirmed non-metastatic BR/LAPC evaluated to potentially tolerate any of the treatment regimens and pancreatic surgery will be randomized to receive either standard duration NAT with 6 cycles mFOLFIRINOX or 4 cycles GnP or prolonged duration NAT with either 12 cycles mFOLFIRINOX or 6 cycles GnP before attempt for surgical resection, provided there is no evidence of disease progression. The primary objective is to compare the overall survival at 24 months after randomization of all treated patients and among the resected patients with BR/LAPC.

Conditions

  • Locally Advanced Pancreatic Adenocarcinoma
  • Borderline Resectable Pancreatic Carcinoma
  • Pancreas Cancer
  • Neoadjuvant Chemotherapy
  • Surgery
  • Pancreatectomy

Interventions

DRUG

FOLFIRINOX or gemcitabine-nab-paclitaxel

4 months if treatment

DRUG

FOLFIRINOX or gemcitabine-nab-paclitaxel

6 months of treatment

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Elena Rangelova, PhD · Sahlgrenska University Hospital, Västra Götalandsregion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2032-12-31
Completion
2033-12-31
FDA Drug
Yes

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714604 on ClinicalTrials.gov