Clinical trial · Interventional
Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
Phase II Study to Evaluate Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Paused due to COVID. A determination was made to stop the study because it would be impossible to reach the 65% resection rate as outlined in the protocol.
Summary
Brief summary (as posted)
Surgical resection is the only potentially curative treatment for patients with pancreatic cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the extent that resection is prohibited. Nonetheless, retrospective studies have shown that immediate resection in these patients is associated with an increased risk of positive margins, and a margin positive resection does not improve survival over that of patients with unresectable disease. Moreover, even in those patients where a successful resection is achieved, there is a high rate of early metastatic progression suggesting that micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a margin negative resection, provide early control of occult micrometastatic disease, and select those patients without systemic progression who would benefit from surgical resection.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant mFOLFIRINOX | Drug | — | UNRESOLVED |
| Stereotactic body radiotherapy (SBRT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients with borderline resectable pancreatic adenocarcinoma
- description
- Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
- interventionNames
- Drug: neoadjuvant mFOLFIRINOX
- Drug: Stereotactic body radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Number of Participants With and Without R0 Resection
- timeFrame
- Up to 40 weeks
- description
- The primary outcome of this study is the R0 resection count of patients with BRPC treated with neoadjuvant mFOLFIRINOX and SBRT. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. When the study results were entered, rate was replaced with count as the manner in which these data were summarized.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed pancreatic adenocarcinoma * Borderline resectable pancreatic adenocarcinoma, determined centrally by review of a diagnostic CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist, or as determined by EUS, and defined according to the NCCN consensus guidelines * ECOG Performance Status of 0-1 * Age \> 18 * Laboratory parameters as follows: * Absolute neutrophil count \>=1,500/uL * Platelet count \>=100,000/uL * Hemoglobin \>=9 g/dL * Creatinine \<1.5 X ULN or estimated GFR \>30 ml/min * Bilirubin =\<1.5 X ULN * AST and ALT =\<3 X ULN * Negative pregnancy test in women of childbearing potential * Able to have fiducials placed in the pancreas * Patients who received chemotherapy \>5 years ago for malignancies other than pancreatic cancer are eligible Exclusion Criteria: * Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI, or PET scan), or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases * Evidence of invasion into the duodenum or stomach, as determined by EGD/EUS * Prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer * Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabine * Major surgery within 4 weeks of study entry * Other concurrent anticancer therapies * Other malignancy within the past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer) * Evidence of second malignancy at the time of study entry * Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * Grade 2 or greater sensory peripheral neuropathy * Uncontrolled seizure disorder, active neurological disease, or known CNS disease * Significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment * Pregnant or nursing * Other medical condition or reason that, in the opinion of the investigator, would preclude study participation
References
Publications (0)
Data not yet available