EUS-guided placement of fiducial markers for stereotactic body radiation therapy in pancreatic cancer: feasibility, security and a new quality score.
Mariana Figueiredo, Christelle Bouchart, Luigi Moretti...
https://pubmed.ncbi.nlm.nih.gov/33553589Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05083247
Preoperative Treatment With mFOLFIRINOX or Gemcitabine-Nab-Paclitaxel With or Without Isotoxic High-dose Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)
Led by Erasme University Hospital · Updated on 2023-05-23
256
Participants Needed
10
Research Sites
156 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
Researchers are evaluating the addition of isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to preoperative chemotherapy regimens for patients with borderline resectable pancreatic adenocarcinoma. The study focuses on improving surgical outcomes and survival by exploring whether combining radiation therapy with chemotherapy before surgery offers benefits compared to chemotherapy alone. This randomized Phase II trial addresses the uncertainty about the best treatment sequence for this type of pancreatic cancer. Participants first receive 4 cycles of chemotherapy with either mFOLFIRINOX or Gemcitabine plus Nab-Paclitaxel, depending on tolerance. After restaging to assess disease status, those without progression are randomly assigned to one of two groups: Arm A continues with 4 more cycles of chemotherapy followed by surgery, while Arm B receives 1 to 2 additional chemotherapy cycles plus iHD-SBRT radiation therapy before surgery. After surgery, adjuvant chemotherapy is given unless the patient's condition prevents it. Throughout the study, patients undergo clinical and imaging assessments, including vascular evaluations and biomarker measurements like CA 19.9, to monitor disease status. The main outcomes measured include disease-free survival up to about two years and the rate of complete tumor removal (R0 resection) within one year. Secondary assessments cover overall survival, response to treatment, complications, side effects, and quality of life over periods extending up to five years. The trial monitors treatment feasibility and safety, with follow-up for both short- and long-term effects.
CONDITIONS
Brief Title
Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Cytologic or histologic confirmation of adenocarcinoma in the pancreatic head, uncinated process, body, or tail
- Clinical stage T1-4 N0-2 M0
- Borderline resectable disease confirmed by imaging and multidisciplinary board
- Age over 18 years
- No prior chemotherapy or radiation for pancreatic cancer
- ECOG performance status 0 or 1
- No neuropathy grade 2 or higher
- Adequate blood counts and organ function as specified
- CA 19.9 less than 2500 kU/l without cholestasis
You will not qualify if you...
- Evidence of disease outside the pancreas or distant metastases
- Locally advanced unresectable disease as defined by NCCN criteria
- CA 19.9 greater than 2500 kU/l at baseline without cholestasis
- Contraindications to surgery
- Contraindications to mFOLFIRINOX or Gemcitabine-Nab-Paclitaxel chemotherapy
- Prior radiotherapy to the upper abdomen
- Previous treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine
- Age under 18 years
- Major surgery within 4 weeks before study entry
- Uncontrolled active infections or unstable heart conditions
- Other active cancers except certain skin, cervical, or prostate cancers in remission
- Pregnant or breastfeeding women; women of childbearing potential must use reliable contraception
- Use of strong CYP3A4 inhibitors without appropriate discontinuation
- Progressive disease or unacceptable toxicity after initial chemotherapy
- Tumor size over 7.0 cm at randomization
- Massive invasion of stomach or intestines or active ulcers not controlled before radiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Initial Chemotherapy
Duration - Approximately 8 weeks
Participants receive 4 cycles of mFOLFIRINOX or Gemcitabine-Nab-Paclitaxel chemotherapy before restaging to assess disease progression.
4 chemotherapy cycles administered every 2 weeks or weekly depending on regimen
Restaging and Randomization
Duration - 1 to 2 weeks
Participants undergo full restaging including clinical evaluation, imaging, and biomarkers to determine eligibility for further treatment arms.
1 visit (in-person) for assessment
Treatment According to Randomization
Duration - Approximately 8 to 12 weeks
Participants are randomized to either continue chemotherapy alone or receive chemotherapy plus isotoxic high-dose stereotactic body radiation therapy (SBRT) before surgery.
Arm A: 4 additional chemotherapy cycles every 2 weeks; Arm B: 2 chemotherapy cycles, 1 week of SBRT, then 1 or 2 additional chemotherapy cycles
Surgery
Duration - Up to 1 week
Participants undergo surgical resection of pancreatic tumor following completion of preoperative treatment.
1 surgical procedure with hospital stay
Adjuvant Chemotherapy
Duration - Variable based on participant condition
Participants receive adjuvant chemotherapy after surgery unless contraindicated by their condition.
Visits scheduled as per treatment plan
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
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Research Team
J
Jean-Luc Van Laethem, MD PhD
M
Mia Persoons
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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Published Research Related To This Trial
Isotoxic high-dose stereotactic body radiotherapy integrated in a total multimodal neoadjuvant strategy for the treatment of localized pancreatic ductal adenocarcinoma.
Christelle Bouchart, Jean-Luc Engelholm, Jean Closset...
https://pubmed.ncbi.nlm.nih.gov/34691244Isotoxic High-Dose Stereotactic Body Radiotherapy (iHD-SBRT) Versus Conventional Chemoradiotherapy for Localized Pancreatic Cancer: A Single Cancer Center Evaluation.
Martin Manderlier, Julie Navez, Matthieu Hein...
https://pubmed.ncbi.nlm.nih.gov/36497212Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised comparative multicenter phase II trial.
Christelle Bouchart, Julie Navez, Ivan Borbath...
https://pubmed.ncbi.nlm.nih.gov/37735634