Actively Recruiting
Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma
Led by Erasme University Hospital · Updated on 2023-05-23
256
Participants Needed
10
Research Sites
405 weeks
Total Duration
On this page
Sponsors
E
Erasme University Hospital
Lead Sponsor
J
Jules Bordet Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytologic or histologic proof of adenocarcinoma of the pancreatic head, uncinated process, body, or tail
- Clinical stage T1-4N0-2M0 pancreatic cancer
- Borderline resectable tumor confirmed by multidisciplinary board using CT or MRI
- Age over 18 years
- No previous chemotherapy or radiation for pancreatic cancer
- ECOG performance status 0 or 1
- No neuropathy of grade 2 or higher
- Absolute neutrophil count at least 1,500/mm³
- Platelet count at least 100,000/mm³
- Hemoglobin at least 9 g/dL
- Creatinine less than or equal to 1.5 times the upper limit of normal or estimated GFR above 45 mL/min
- Bilirubin less than or equal to 1.5 times the upper limit of normal, including after biliary stenting
- AST and ALT less than or equal to 2.5 times the upper limit of normal
- CA 19.9 less than 2500 kU/l at baseline and no cholestasis
You will not qualify if you...
- Evidence of cancer spread outside the pancreas on imaging or laparoscopy
- Locally advanced disease not suitable for surgery by NCCN criteria
- CA 19.9 above 2500 kU/l at baseline without cholestasis
- Any contraindication to surgery
- Contraindications to receive mFOLFIRINOX or gemcitabine-nab-paclitaxel
- Previous radiation to the upper abdomen
- Prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine
- Age under 18 years
- Major surgery within 4 weeks before study entry
- Uncontrolled diseases such as active infection, heart failure, unstable angina, or psychiatric disorders limiting consent
- Use of other anticancer treatments
- Other active cancers except basal cell skin carcinoma, cervical carcinoma in situ, or non-metastatic prostate cancer unless in remission over 5 years
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test and use reliable contraception
- Use of strong CYP3A4 inhibitors within 14 days before study entry
- Progressive disease or significant tumor growth after initial chemotherapy
- CA 19.9 above 1000 kU/l after neoadjuvant therapy
- Unmanageable toxicity during initial chemotherapy
- Tumor size over 7.0 cm at randomization
- Major invasion of stomach or intestines or active gastric/duodenal ulcers at randomization except healed ulcers confirmed by endoscopy
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Uza Antwerp
Antwerp, Belgium, 2650
Actively Recruiting
2
Hopital Erasme, HUB
Brussels, Belgium, 1070
Actively Recruiting
3
Jules Bordet Institute, HUB
Brussels, Belgium, 1070
Actively Recruiting
4
CHIREC
Brussels, Belgium, 1160
Actively Recruiting
5
Cliniques Universitaires St luc
Brussels, Belgium, 1200
Actively Recruiting
6
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
7
AZ Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
8
Pôle Hospitalier Jolimont
La Louvière, Belgium, 7100
Actively Recruiting
9
Clinique Chc Montlégia
Liège, Belgium, 4000
Actively Recruiting
10
CHU Ambroise Paré
Mons, Belgium, 7000
Actively Recruiting
Research Team
J
Jean-Luc Van Laethem, MD PhD
CONTACT
M
Mia Persoons
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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