Brief Summary

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Trial Health

On Track

Trial Health Score

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

Enrollment

358

participants targeted

Target at P50-P75 for phase_3

Timeline

55mo left

Started Oct 2020

Longer than P75 for phase_3

Geographic Reach

2 countries

453 active sites

Status

active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

10.1 years study duration

Study Progress55%

Oct 2020Nov 2030

First Submitted

Initial submission to the registry

April 7, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed

8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

8.2 years

First QC Date

April 7, 2020

Last Update Submit

February 9, 2026

Conditions

Pancreatic Adenosquamous Carcinoma Resectable Pancreatic Adenocarcinoma Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

Overall survival (OS)
Overall survival is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. The treatment arms will be compared using a stratified Cox regression model, and hazard ratios from each arm will be estimated.
Time between randomization and death from any cause, assessed up to 6 years.

Secondary Outcomes (15)

Disease-free survival (DFS)
Time between randomization and progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to all causes, assessed up to 6 years.
Time to locoregional recurrence (TLR)
Time between randomization and locoregional recurrence after resection, assessed up to 6 years.
Time to distant metastases (TDM)
Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 6 years.
R0 resection rate
At time of surgery.
Rate of unresectability
At time of surgery or planned time of surgery.
+10 more secondary outcomes

Study Arms (2)

Arm I (perioperative chemotherapy, surgery)

EXPERIMENTAL

Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Drug: OxaliplatinDrug: Irinotecan HydrochlorideDrug: Leucovorin CalciumDrug: FluorouracilProcedure: ResectionOther: Questionnaire Administration

Arm II (surgery, adjuvant chemotherapy)

ACTIVE COMPARATOR

Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Drug: OxaliplatinDrug: Irinotecan HydrochlorideDrug: Leucovorin CalciumDrug: FluorouracilProcedure: ResectionOther: Questionnaire Administration