Comparing standard and prolonged chemotherapy before surgery for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled phase III trial aims to evaluate the effectiveness of two different durations of neoadjuvant chemotherapy in patients with borderline resectable and locally advanced pancreatic cancer. Participants will be assigned to receive either standard duration chemotherapy with mFOLFIRINOX or gemcitabine-nab-paclitaxel, or a prolonged duration of these treatments before attempting surgical resection. The primary goal is to assess overall survival rates at 24 months post-randomization, particularly focusing on those who undergo surgery. The study seeks to improve outcomes for patients who typically have poor prognoses due to the challenging nature of pancreatic cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• SahlgrenskaUH
  Gothenburg, Vgr, Sweden Recruiting

Study contacts

• Principal investigator: Elena Rangelova, PhD — Sahlgrenska University Hospital, Västra Götalandsregion
• Study coordinator: Elena Rangelova, PhD
• Email: elena.rangelova@gu.se
• Phone: +46 31 34 28 216

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.