Brief Summary

The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

378

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Timeline

38mo left

Started Sep 2021

Longer than P75 for phase_3 pancreatic-cancer

Geographic Reach

3 countries

22 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.8 years study duration

Study Progress60%

Sep 2021Jul 2029

First Submitted

Initial submission to the registry

June 8, 2021

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed

3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Expected

Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

4.4 years

First QC Date

June 8, 2021

Last Update Submit

August 27, 2024

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Adenocarcinoma

Keywords

Neoadjuvant TherapyAdjuvant ChemotherapyOxaliplatinIrinotecanLeucovorinFluorouracilPancreatic NeoplasmsPancreatectomy

Outcome Measures

Primary Outcomes (1)

Overall survival
The time between randomization and death from any cause. Patients alive at last follow-up are censored.
Up to 5 years after randomization.

Secondary Outcomes (27)

Progression free survival
Up to 5 years after randomization.
Distant metastases free survival
Up to 5 years after randomization.
Locoregional progression free survival
Up to 5 years after randomization.
Distant metastases free interval
Up to 5 years after randomization.
Locoregional progression free interval
Up to 5 years after randomization.
+22 more secondary outcomes

Study Arms (2)

Arm 1: Perioperative mFOLFIRINOX

EXPERIMENTAL

Patients in the intervention arm (arm 1) start with neoadjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours). Cycles are repeated every 14 days. After eight cycles, surgical resection is performed in the absence of unresectable or metastatic disease. After resection, four cycles of adjuvant mFOLFIRINOX are scheduled.

Drug: Leucovorin CalciumDrug: FluorouracilDrug: Irinotecan HydrochlorideDrug: OxaliplatinProcedure: Resection

Arm 2: Adjuvant mFOLFIRINOX

ACTIVE COMPARATOR

Patients in the comparator arm (arm 2) start with surgery. After resection, 12 cycles of adjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours) are scheduled.

Drug: Leucovorin CalciumDrug: FluorouracilDrug: Irinotecan HydrochlorideDrug: OxaliplatinProcedure: Resection