RecruitingPhase 2NCT05083247

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

Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)


Sponsor

Erasme University Hospital

Enrollment

256 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a focused radiation treatment (called SBRT) to standard chemotherapy before surgery can improve outcomes for people with borderline resectable pancreatic cancer — cancer that sits near important blood vessels and may or may not be removable by surgery. **You may be eligible if...** - You have been diagnosed with pancreatic cancer (adenocarcinoma) and scans show it is "borderline resectable" — meaning surgery might be possible - You are 18 or older - You have not had any prior chemotherapy or radiation for pancreatic cancer - You are in reasonably good physical health (able to carry out daily activities) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - The cancer has spread beyond the pancreas to distant sites or lymph nodes - The cancer is too locally advanced (wrapping around major arteries) - You have had previous radiation to the upper abdomen - You have a serious uncontrolled medical condition - You are pregnant or breastfeeding - You are under 18 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFIRINOX or Gemcitabine nab-paclitaxel

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

RADIATIONIsotoxic High-Dose (iHD)-SBRT

Radiation therapy

PROCEDURESurgery

Surgery


Locations(10)

Uza Antwerp

Antwerp, Belgium

Hopital Erasme, HUB

Brussels, Belgium

Jules Bordet Institute, HUB

Brussels, Belgium

CHIREC

Brussels, Belgium

Cliniques Universitaires St luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

Pôle Hospitalier Jolimont

La Louvière, Belgium

Clinique Chc Montlégia

Liège, Belgium

CHU Ambroise Paré

Mons, Belgium

View Full Details on ClinicalTrials.gov

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NCT05083247


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