RecruitingPhase 3NCT06714604

Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled

Sponsor

Sahlgrenska University Hospital

Enrollment

432 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to treating borderline or locally advanced pancreatic cancer before surgery: standard-length chemotherapy versus a longer course. Researchers want to find out if giving chemotherapy for longer before operating improves outcomes. **You may be eligible if...** - You have been diagnosed with borderline or locally advanced pancreatic adenocarcinoma (a type of pancreatic cancer) - Your cancer has been confirmed by biopsy or cell sample - You are in good health and fit enough for surgery and chemotherapy (ECOG 0–1) - Your cancer has not spread to distant organs (no distant metastases) **You may NOT be eligible if...** - You have health conditions that prevent you from having surgery or chemotherapy - You have significant nerve damage (neuropathy grade 2 or higher) - You have poor blood counts, kidney, liver, or nutritional markers - You are pregnant or breastfeeding - You have had prior treatment for pancreatic cancer in the last 5 years - You are currently participating in another drug trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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