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Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma

NCT05083247 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-05-23

No results posted yet for this study

Summary

Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.

Conditions

  • Pancreatic Neoplasm
  • Pancreatic Adenocarcinoma
  • Borderline Resectable Pancreatic Adenocarcinoma

Interventions

DRUG

mFOLFIRINOX or Gemcitabine nab-paclitaxel

oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel

RADIATION

Isotoxic High-Dose (iHD)-SBRT

Radiation therapy

PROCEDURE

Surgery

Surgery

Sponsors & Collaborators

  • Jules Bordet Institute

    collaborator OTHER

  • Belgian Group of Digestive Oncology

    collaborator OTHER

  • University Hospital St Luc, Brussels

    collaborator OTHER

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Jean-Luc Van Laethem, MD · Erasme Hospital, ULB

  • Christelle Bouchart, MD · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083247 on ClinicalTrials.gov