Chemotherapy before or after surgery in patients with resectable pancreatic cancer: the PREOPANC-3 study.

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864; non-metastatic resectable pancreatic cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005141-16-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

• Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
• Resectable tumor according to DPCG 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 109/L
• Platelets = 100X 109/L
• Hemoglobin = 6.0 mmol/l
• Renal function: eGFR = 40 ml/min
• Age = 18 years
• Written informed consent

* Lesions on chest CT that are too small to characterize are not considered metastatic disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 189

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified