Clinical trial · Interventional
Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer
The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer
NCT02128100CI-TRIAL-00074692BCC-RAD-13completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.
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 Non-resectable | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folfirinox | Drug | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Folririnox with SBRT
- description
- Folfirinox * Oxaliplatin 85 mg/m² for over 2 hours, * Leucovorin 400n mg/m² for over 2 hours, * Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion * Fluorouracil 400 mg/m² as a fast infusion over 15 minutes * Fluorouracil 2400 mg/m² as a slow infusion over 46 hours SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment.
- interventionNames
- Drug: Folfirinox
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability
- timeFrame
- Assessed up to 24 months post treatment
- description
- Number of Participants With Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability. This is based on CTCAE to assess toxicity at specified time points by the treating physician.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years * ECOG performance status 0-1 * Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy. * Imaging as follows: * CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration * Whole body PET scan within 8 weeks of registration * Evaluation by a surgical oncologist to determine non-resectability * Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. * CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows: * ANC \> 1,500 cell/mm3 * Platelets \> 100,000 cells/mm3 * Hemoglobin \> 8.0 g/dl (transfusion to obtain this value is permissible) * Additional labs within 14 days prior to registration * CA 19-9 * Creatinine \<2mg/dl * Bilirubin \<2mg/dl * AST and ALT \< 2.5 x ULN * Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: * Metastatic disease as defined by the multi-disciplinary team * Prior anti-cancer therapy for a pancreatic tumor * Prior malignancy within the last 3 years. * Pregnant women or lactating women * Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
References
Publications (0)
Data not yet available
No reference posted for this study.