Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

Launched by ERASMUS MEDICAL CENTER · Jun 15, 2021

Keywords

ClinConnect Summary

The PREOPANC-3 study is a clinical trial exploring the best way to treat patients with resectable pancreatic cancer, which means the cancer can be surgically removed. In this trial, participants will be randomly assigned to one of two treatment groups. One group will receive chemotherapy (called mFOLFIRINOX) before and after surgery, while the other group will have surgery first and then chemotherapy afterward. The main goal is to see if starting chemotherapy before surgery can help patients live longer compared to starting it after surgery.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of pancreatic ductal adenocarcinoma, with a tumor that meets specific criteria for being operable. They should be in good overall health and able to undergo both surgery and chemotherapy. However, those who have had prior treatment for pancreatic cancer, are pregnant, or have certain serious health conditions may not be eligible. Participants can expect to receive close medical supervision and support throughout the study. This trial is currently recruiting participants, and it's an important opportunity to contribute to research that could improve treatment outcomes for pancreatic cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
• • Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less
• • No evidence for metastatic disease
• • WHO performance status of 0 or 1
• • Ability to undergo surgery and mFOLFIRINOX chemotherapy
• • Leucocytes (WBC) ≥ 3.0 x 10\^9/L
• • Platelets ≥ 100 x 10\^9/L
• • Hemoglobin ≥ 6.0 mmol/l
• • Renal function: eGFR ≥ 40 ml/min
• • Age ≥ 18 years
• • Written informed consent
• Exclusion Criteria:
• • Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
• • Prior chemotherapy precluding mFOLFIRINOX.
• • Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \<2cm, and gastrointestinal stromal tumor (GIST) \<2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
• • Pregnancy or lactation.
• • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.