Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the best duration of chemotherapy before surgery for patients with borderline or locally advanced pancreatic cancer. The researchers want to compare two approaches: a standard treatment with a shorter course of chemotherapy (6 cycles of mFOLFIRINOX or 4 cycles of gemcitabine-nab-paclitaxel) versus a prolonged treatment with a longer course (12 cycles of mFOLFIRINOX or 6 cycles of gemcitabine-nab-paclitaxel). The main goal is to see which approach helps patients live longer after treatment and surgery.

To participate, patients should be diagnosed with non-metastatic borderline or locally advanced pancreatic cancer that can be treated with surgery. They should also be healthy enough to handle chemotherapy and surgery, and they must give written consent to join the study. During the trial, participants will receive either the standard or prolonged chemotherapy before having surgery, as long as their condition doesn't worsen. This trial is currently recruiting patients and is open to individuals aged 18 and older, regardless of gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1.2022
• • Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)
• • T1-4, Nx, M0 according to AJCC 8th edition
• • ECOG 0-1 and considered fit for the planned chemotherapy at the local hospital and surgery at the two national centers for BR/LAPC
• • Written informed patient consent
• Exclusion Criteria:
• • Co-morbidity precluding pancreatic surgery or chemotherapy
• • Contraindications to any of the drugs in the proposed treatment regimens
• • ECOG ≥2
• • Neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6
• • Granulocyte count \< 1500 per cubic millimetre (\< 1,5 x 109/L)
• • Platelet count \< 100 000 per cubic millimetre (\< 100 x 109/L)
• • Serum creatinine \> 1.5 UNL (upper limit normal range)
• • Albumin \<2,5 g/dl (\<25 g/L)
• • Total bilirubin \>3 x ULN
• • ASAT (SGOT) and ALAT (SGPT) \>2.5 x institutional ULN
• • female patients in child-bearing age not using adequate contraception, pregnant or lactating women
• • mental or somatic disorders which could possibly interfere with informed consent, compliance or the planned treatments
• • previous oncologic treatment for PC within the past 5 years
• • participation in other clinical trial with an investigational product during the past 30 days
• • Any reason according to the investigator why the patient cannot comply with the protocol or is not suitable to participate