Actively Recruiting
Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
Led by Sahlgrenska University Hospital · Updated on 2024-12-03
432
Participants Needed
1
Research Sites
532 weeks
Total Duration
On this page
Sponsors
S
Sahlgrenska University Hospital
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. The primary objective is to compare the overall survival at 24 months after randomization of all treated patients and among the resected patients with BR/LAPC.
CONDITIONS
Official Title
Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to NCCN Clinical Practice Guidelines, version 1.2022
- Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)
- Tumor stage T1-4, any lymph node status, no distant metastasis (M0) according to AJCC 8th edition
- ECOG performance status 0-1 and fit for chemotherapy and surgery at designated centers
- Signed informed patient consent
You will not qualify if you...
- Other health conditions that prevent pancreatic surgery or chemotherapy
- Contraindications to any drugs planned in the study treatment
- ECOG performance status 2 or higher
- Neuropathy grade 2 or higher according to CTCAE version 6
- Granulocyte count less than 1500/mm3 (1.5 x 10^9/L)
- Platelet count less than 100,000/mm3 (100 x 10^9/L)
- Serum creatinine above 1.5 times the upper normal limit
- Albumin below 2.5 g/dL (25 g/L)
- Total bilirubin more than 3 times the upper normal limit
- ASAT (SGOT) and ALAT (SGPT) more than 2.5 times institutional upper normal limit
- Women of childbearing potential not using effective contraception, pregnant or breastfeeding women
- Mental or physical disorders interfering with consent, compliance, or planned treatments
- Previous cancer treatment for pancreatic cancer within 5 years
- Participation in another clinical trial with an investigational product within past 30 days
- Any other reason judged by the investigator that makes the patient unsuitable for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
SahlgrenskaUH
Gothenburg, VGR, Sweden, 41345
Actively Recruiting
Research Team
E
Elena Rangelova, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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