Clinical trial · Interventional
Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer
Phase I Study of Stereotactic Body Radiation Therapy and 5-Fluorouracil, Oxaliplatin and Irinotecan (FOLFIRINOX) in the Neoadjuvant Therapy of Pancreatic Cancer
- 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)
The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer after it is resected surgically. In addition, the investigators will perform biochemical studies on the tumor tissue obtained from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in the behavior of pancreatic cancer cells. The data obtained from this trial will be extremely valuable to help improve the approach to treating pancreatic cancer in the future. If you do not undergo surgery after completion of FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer tomography (CT) -guidance in order to measure the effect of treatment on your tumor.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Cancer of the Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Neoplasms, Pancreatic | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified FOLFIRINOX | Drug | — | UNRESOLVED |
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-Fluorouracil, Oxaliplatin, Irinotecan
- description
- 5-Fluorouracil, Oxaliplatin, Irinotecan are administered as a modified FOLFIRINOX regimen every 15 days. Subjects receive bi-weekly cycles of therapy on the 1st week, the 3rd week, the 5th week and finally the 7th week for a total of 4 cycles. Assessments include history and physical, laboratory tests on a weekly basis throughout the treatment period prior to and including week 8 assessment for stereotactic body radiotherapy (SBRT).
- interventionNames
- Drug: Modified FOLFIRINOX
- Radiation: Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Maximum tolerated total dose of stereotactic body radiation to patients with resectable or borderline resectable pancreas cancer following FOLFIRINOX chemotherapy
- timeFrame
- Four weeks
- description
- A standard 3 + 3 design will be used for evaluating the safety and tolerability of SBRT radiation doses. Any grade 3 liver, gastric, small bowel or spinal cord toxicity or any grade 4 toxicity (hematologic or other non-hematologic except for diarrhea) will be considered a dose limiting toxicity (DLT). Each cohort will consist of 3 patients, unless 1 of the patients experiences a DLT in which case the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will be defined as the dose level below that which results in a DLT in 2 or more of the 6 patients in a cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Patients eligible must have: * Histologic or cytologic diagnosis of pancreatic adenocarcinoma. * Radiographically resectable or borderline resectable disease as reviewed by an experienced surgical oncologist at Emory. * Age 21 years or older. * Not received prior chemotherapy or radiation for pancreatic cancer. * ECOG performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Adequate bone marrow function: absolute neutrophil count \> 1,500/cmm, platelet count \> 100,000/cmm. * Understanding and be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol. Exclusion Criteria: Patients who are not eligible have * Histologies including endocrine tumors or lymphoma of the pancreas. * A tumor which is less than 3 mm from the duodenum as measured by either CT or MRI. * History of central nervous system (CNS) metastases. * Liver dysfunction, including total bilirubin \> 1.5 mg/dL; aspartate transaminase (AST) and alanine amino transferase (ALT) \> 5 times upper limit of the institutional normal. * Creatinine ≥ 1.5 mg/dL. * Albumin ≤ 2.5 g/dL. * International Normalized Ratio (INR) ≥ 1.5 (in the absence of ongoing treatment with warfarin). * Breast feeding. * Serious active infection. * Serious concurrent systemic disorders incompatible with participating in the study (at the discretion of the investigator). * An active second primary malignancy (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study. * Clinical evidence of distant metastatic disease.
References
Publications (1)
- DERIVEDShaib WL, Hawk N, Cassidy RJ, Chen Z, Zhang C, Brutcher E, Kooby D, Maithel SK, Sarmiento JM, Landry J, El-Rayes BF. A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458). Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):296-303. doi: 10.1016/j.ijrobp.2016.05.010. Epub 2016 May 24. PMID 27475674