Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Progression free survival

The time between randomization and locoregional progressive disease before or during treatment (resulting in irresectability), the occurrence of distant metastases, recurrent pancreatic cancer after surgery or death from any cause. Patients alive and free of these events at last follow-up are censored.

Time frame: Up to 5 years after randomization.

Distant metastases free survival

The time between randomization and the occurrence of distant metastases or death from any cause. Patients alive and free of these events at last follow-up are censored.

Time frame: Up to 5 years after randomization.

Locoregional progression free survival

The time between randomization and locoregional progression before or during treatment (resulting in irresectability), locoregional recurrence after resection or death from any cause. Patients alive and free of these events at last follow-up are censored.

Time frame: Up to 5 years after randomization.

Distant metastases free interval

The time between randomization and the occurrence of distant metastases. Distant metastases are considered an event and patients are censored at death or last follow-up when without this event.

Time frame: Up to 5 years after randomization.

Locoregional progression free interval

The time between randomization and locoregional progression before or during treatment (resulting in irresectability), or locoregional recurrence after resection. Locoregional progressive disease before or during treatment or locoregional recurrence after resection are considered an event and patients are censored at death or last follow-up when free of these events.

Time frame: Up to 5 years after randomization.

Chemotherapy start rate

The percentage of patients who received at least one cycle of scheduled chemotherapy.

Time frame: 4 months

Number of chemotherapy cycles received.

The number of mFOLFIRINOX cycles patients received.

Time frame: 9 months

Chemotherapy completion rate

The percentage of patients who completed all cycles of scheduled chemotherapy.

Time frame: 9 months

Dose intensity

The amount of drug delivered as a percentage of planned dose according to the protocol.

Time frame: 9 months

Staging laparoscopy rate

The percentage of patients that actually underwent a staging laparoscopy, regardless whether a surgical exploration or resection was performed.

Time frame: At the time of surgery.

Laparoscopy yield

The percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic or unresectable disease during this procedure.

Time frame: At the time of surgery.

Surgical exploration rate

The percentage of patients who underwent a surgical exploration (open or minimally-invasive), regardless whether a resection was performed.

Time frame: At the time of surgery.

Resection rate

The percentage of patients that underwent a curative-intent resection.

Time frame: At the time of surgery.

Microscopically margin-negative (R0) resection rate

The percentage of patients that underwent a microscopically margin-negative (R0) resection. The resection is considered R0 if there is no tumor within 1 mm of the margins.

Time frame: At the time of surgery.

Lymph node-negative (N0) resection rate

The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen.

Time frame: At the time of surgery.

Pathologic response

Tumor regression score in the surgical specimen

Time frame: At the time of surgery.

Adverse events as assessed by the CTCAE version 5.0

Adverse events are assessed during neoadjuvant therapy and adjuvant therapy.

Time frame: Until 30 days after last chemotherapy.

Postoperative complications

According to the Clavien-Dindo classification and by the International Study Group of Pancreatic Surgery and International Study Group of Liver Surgery.

Time frame: Up to 90 days after surgery.

Serum CA 19-9 and CEA response

The change in carbohydrate antigen 19-9 (CA 19-9) and carcinoembryonic antigen (CEA) after surgery and after 4, 8, and 12 cycles of mFOLFIRINOX compared to baseline.

Time frame: 9 months

Clinical response rate according to RECIST criteria version 1.1

Response comparing baseline and restaging after 4 and 8 cycles of mFOLFIRINOX

Time frame: At the time of surgery.

Patient reported cancer-specific health-related Quality of Life (HRQoL) as assessed using the EORTC QLQ-C30

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.

Patient reported non-disease specific HRQoL as assessed using the EQ-5D-5L

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.

Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.

Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.

Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.

Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.

Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire

At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Time frame: Up to 5 years after randomization.