Comparing standard and prolonged chemotherapy before surgery for pancreatic cancer
Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled
This study is testing whether giving longer chemotherapy before surgery can help people with tough-to-treat pancreatic cancer live longer and have better outcomes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gothenburg, VGR) |
| Trial ID | NCT06714604 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed borderline or locally advanced pancreatic adenocarcinoma who are fit for chemotherapy and surgery.
Not a fit: Patients with significant comorbidities that prevent them from undergoing surgery or chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with borderline and locally advanced pancreatic cancer.
How similar studies have performed: Previous studies have shown promising results with neoadjuvant chemotherapy in pancreatic cancer, suggesting that this approach may be beneficial, although the specific comparison of durations is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg, VGR
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.