NCT06714604RecruitingPhase 3
Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 432 (estimated)
- First submitted
- 21 Feb 2023
- Start date
- 18 Oct 2023
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- Sahlgrenska University Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT06714604
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 432
- From 18 Oct 2023 to the primary completion date, 31 Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Co-morbidity precluding pancreatic surgery or chemotherapy
- Contraindications to any of the drugs in the proposed treatment regimens
- previous oncologic treatment for PC within the past 5 years
- participation in other clinical trial with an investigational product during the past 30 days
Other illness
- mental or somatic disorders which could possibly interfere with informed consent, compliance or the planned treatments
Lab values
- 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
Age
- female patients in child-bearing age not using adequate contraception, pregnant or lactating women
Other
- ECOG ≥2
- Neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6
- Any reason according to the investigator why the patient cannot comply with the protocol or is not suitable to participate
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SahlgrenskaUH Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.