Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

NCT06714604 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2022-502117-29-00
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Carcinoma; Pancreas Cancer; Neoadjuvant Chemotherapy; Surgery; Pancreatectomy

Outcome Measures

Primary Outcomes (2)

• Overall survival of all BR/LAPC patients

  Comparison of overall survival of all enrolled BR/LAPC patients treated with the standard or the prolonged treatment

  24 months of randomization

• Overall survival of all resected BR/LAPC patients

  Comparison of overall survival of the resected BR/LAPC patients treated with the standard or the prolonged treatment

  24 months of randomization

Secondary Outcomes (15)

• Overall survival in intention-to-treat and per protocol treated

  60 months

• Progression-free survival (PFS) in intention-to-treat and per protocol treated

  60 months

• Overall survival among non-resected BR/LAPC patients

  24 months

• Overall and progression-free survival among all and among resected patients with BR in the two arms in ITT

  60 months

• Overall and progression-free survival among all and among resected patients with LAPC in the two arms in ITT

  60 months

Study Arms (2)

Standard

ACTIVE COMPARATOR

8 cycles of neoadjuvant mFOLFIRINOX or 4 cycles of neoadjuvant gemcitabine-nab-paclitaxel

Drug: FOLFIRINOX or gemcitabine-nab-paclitaxel

Prolonged

EXPERIMENTAL

12 cycles of neoadjuvant mFOLFIRINOX or 6 cycles of neoadjuvant gemcitabine-nab-paclitaxel

Drug: FOLFIRINOX or gemcitabine-nab-paclitaxel

Interventions

FOLFIRINOX or gemcitabine-nab-paclitaxel DRUG

4 months if treatment

Standard

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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)
• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

SahlgrenskaUH

Gothenburg, VGR, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Elena Rangelova, PhD

  Sahlgrenska University Hospital, Västra Götalandsregion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Rangelova, PhD

CONTACT

+46 31 34 28 216; elena.rangelova@gu.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled two-arm open label phase 3 trial

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: December 3, 2024
• Study Start: October 18, 2023
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2033
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

SE (1)