Clinical trial · Interventional
Borderline Pancreas Study: FOLFIRINOX +SBRT
Neoadjuvant FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) Followed by Definitive Surgery for Patients With Borderline Resectable Pancreatic Adenocarcinoma: A Single-Arm Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. Secondary Objective(s): 1. To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT 2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer 3. To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy 4. To assess quality of life through and after treatment using the FACT-Hep questionnaire
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours | Drug | — | UNRESOLVED |
| Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable | Other | — | UNRESOLVED |
| -Irinotecan 180 mg/m2 IV on Day 1 | Drug | — | UNRESOLVED |
| -Oxaliplatin 85 mg/m2 IV on Day 1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Chemotherapy+SBRT prior to surgery if applicable
- description
- FOLFIRINOX Drugs: * Calcium Folinate (Folinic Acid) 400 mg IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles. Stereotactic Body Radiotherapy (SBRT): 30 Gy in 5 fractions given to radiographically defined pancreatic mass alone
- interventionNames
- Other: Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable
- Drug: -Oxaliplatin 85 mg/m2 IV on Day 1
- Drug: -Irinotecan 180 mg/m2 IV on Day 1
- Drug: -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours
Primary outcomes (1)
- measure
- Rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy.
- timeFrame
- Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.
- description
- To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy (AGGC 6th edition).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years at diagnosis. * Biopsy proven pancreatic adenocarcinoma. * Borderline resectable per NCCN criteria (No distant metastases, venous involvement of the portal vein/SMV, demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the SMA not to exceed 180 degrees of the circumference of the vessel wall.). * Radiologically measurable or clinically evaluable disease. * Pancreas protocol CT and/or MRI if required for further clarification of disease tissue planes within 4 weeks of registration. * ECOG PS of 0-2. * Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration. * The following laboratory values obtained ≤ 28 days prior to registration: * Absolute neutrophil count (ANC) ≥ 1,500/mm3. * Platelet count ≥ 100,000/mm3. * Hemoglobin \> 8.0 g/dL. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * SGOT (AST) ≤ 2 x ULN. * SGPT (ALT) ≤ 2 x ULN. * Creatinine ≤ 1.5 x ULN. * CA 19-9 level (to establish baseline). * A negative pregnancy test within 7 days prior to registration for women of childbearing potential. In addition, male and female participants must commit to adequate contraception while on study. * Able to provide written informed consent. * Willing to return for all required study assessments. * Neurological assessment for pre-existing peripheral neuropathy. * Documentation of pre-existing hearing deficits. Exclusion Criteria: * Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease. * Prior history of abdominal radiation therapy. * History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease. * Patients with tumor-caused symptomatic bowel obstruction. * Chemotherapy (including hormonal therapy) within the past 5 years from date of registration. * Other invasive malignancies within the past 5 years from date of registration. * Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception. * Other co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.
References
Publications (0)
Data not yet available