Preoperative chemotherapy with radiation for borderline resectable pancreatic cancer
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)
This study is testing whether adding a specific type of radiation therapy to chemotherapy before surgery can help people with borderline resectable pancreatic cancer have better outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasme University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 10 sites (Antwerp and 9 other locations) |
| Trial ID | NCT05083247 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding isotoxic high-dose stereotactic body radiation therapy (iHD-SBRT) to preoperative chemotherapy regimens (mFOLFIRINOX or Gemcitabine nab-paclitaxel) in patients with borderline resectable pancreatic adenocarcinoma. Participants will receive four cycles of chemotherapy, followed by restaging, and those without disease progression will be randomized to either continue chemotherapy or receive additional cycles followed by iHD-SBRT before surgery. The goal is to determine the optimal treatment sequence to improve surgical outcomes and survival rates.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed borderline resectable pancreatic adenocarcinoma who have not received prior chemotherapy or radiation.
Not a fit: Patients with advanced pancreatic cancer beyond borderline resectable status or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the chances of surgical resection and improve survival outcomes for patients with borderline resectable pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with neoadjuvant therapies for pancreatic cancer, but the specific combination of iHD-SBRT with mFOLFIRINOX or Gem-Nab-P is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist * cTNM stage: T1-4N0-2M0 * Confirmation of clinical and radiographic stage as borderline resectable (CT scan and/or MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist) * Age \> 18 years old * No prior chemotherapy or radiation for pancreatic cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * No grade ≥ 2 neuropathy * Laboratory parameters as follows: * Absolute neutrophil count (ANC) ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR \>45 mL/min * Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5x ULN * CA 19.9 \< 2500 kU/l (baseline, prior to any therapy and absence of cholestasis) Exclusion Criteria: * Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI or PET scan), histologically proven or at laparoscopy, including distal nodal involvement beyond the peripancreatic tissues (including non-regional lymph node involvement, ie: proven involvement of precaval lumbar lymphadenopathy(ies) and/or distant metastases * Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie \> 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV/PV) due to tumor involvement or occlusion of a long segment. * CA 19.9 \> 2500 kU/l (baseline and absence of cholestasis) * Contraindication of surgery (general) * Contraindications to receive FFX or gemcitabine-nab-Paclitaxel * History of radiotherapy of the upper abdomen * Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin * Patient \< 18 years old * Major surgery within 4 weeks of study entry * Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social / psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form * Other concurrent anticancer therapies * Existence of another active neoplasia other than basal cell carcinoma of the skin, cervical carcinoma in situ or non-metastatic prostate cancer. Patients who have a history of neoplasia must have been in remission for more than 5 years to be included in the protocol * Pregnant or breastfeeding women; for women of childbearing potential only, a negative pregnancy test done \< 7 days prior to registration is required. Using of reliable contraception for at least 1 month before treatment is mandatory * Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study Additional exclusion criteria before randomisation: * Progressive disease (RECIST or PETCT, including non locoregional nodal involvement and increase of CA 19.9 by 20%) after receiving 4 cycles of FFX (or G/NP), including shift chemotherapy in case of early progression. * CA 19.9 \> 1000 kU/l after neoadjuvant therapy. * Presence of unmanageable toxicity during the first part of neoadjuvant chemotherapy (first 4 cycles or 6 doses of FFX or G/NP, respectively. * Pancreatic tumour \> 7.0 cm in greatest axial dimension at the time of randomization * Massive invasion of the stomach or intestines and/or direct intestinal invasion of the mucosae visible at ultrasoundendoscopy * Active gastric or duodenal ulcer disease at the time of randomization. Tolerated in case of antecedent without active ulcer (confirmation by endoscopy before iHD-SBRT)
Where this trial is running
Antwerp and 9 other locations
- Uza Antwerp — Antwerp, Belgium (Recruiting)
- Hopital Erasme, HUB — Brussels, Belgium (Recruiting)
- Jules Bordet Institute, HUB — Brussels, Belgium (Recruiting)
- Chirec — Brussels, Belgium (Recruiting)
- Cliniques Universitaires St luc — Brussels, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
- Pôle Hospitalier Jolimont — La Louvière, Belgium (Recruiting)
- Clinique Chc Montlégia — Liège, Belgium (Recruiting)
- CHU Ambroise Paré — Mons, Belgium (Recruiting)
Study contacts
- Principal investigator: Christelle Bouchart, MD — Jules Bordet Institute
- Study coordinator: Jean-Luc Van Laethem, MD PhD
- Email: jl.vanlaethem@erasme.ulb.ac.be
- Phone: 003225553714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.