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New treatment option for Locally Advanced Pancreatic Adenocarcinoma
Official title Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
ClinicalTrials.gov ID: NCT06714604
What this study is testing
What is FOLFIRINOX or gemcitabine-nab-paclitaxel?
FOLFIRINOX or gemcitabine-nab-paclitaxel is an investigational medicine, being studied as a potential treatment for locally advanced pancreatic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this multicenter randomized controlled phase III trial is to compare two durations of neoadjuvant chemotherapy (NAT) with mFOLFIRINOX or gemcitabine-nab-paclitaxel (GnP) before attempt for surgical resection in patients with borderline (BR) and locally advanced pancreatic cancer (LAPC). Patients with histologically confirmed non-metastatic BR/LAPC evaluated to potentially tolerate any of the treatment regimens and pancreatic surgery will be randomized to receive either standard duration NAT with 6 cycles mFOLFIRINOX or 4 cycles GnP or prolonged duration NAT with either 12 cycles mFOLFIRINOX or 6 cycles GnP before attempt for surgical resection, provided there is no evidence of disease progression.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice...
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, VGR, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, VGR, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.