Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Withdrawn before enrolling · Phase 2
Conditions studied: Pancreatic Cancer, Pancreatic Adenocarcinoma
In brief
The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.
Key facts
- Study ID
- NCT04130399
- Run by
- Indiana University
- People needed
- 0
- Starts
- 2019-07-01
- Expected to finish
- 2023-01-01
- Last updated by the study team
- 2019-10-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Pathologic confirmation of pancreatic ductal adenocarcinoma
- Resectable disease (determined by treating surgeon)
- Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment
- No evidence of distant organ metastatic disease
- Eastern Cooperative Oncology Group Performance status 0-1
- Ability to understand and the willingness to sign informed consent document
- Adequate organ function, defined by the following laboratory values, at the time of study entry:
- Hemoglobin ≥ 10 g/dL (transfusions acceptable)
- Absolute Neutrophil Count ≥ 0.5 x 109/L
- Platelets ≥ 100 x 109/L
- Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
- Total bilirubin ≤ 2x institutional ULN
- Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD
You may not qualify if…
- Severe/uncontrolled intercurrent illness that, in the opinion of the patient's treating physicians, would prevent the patient from receiving either multi agent chemotherapy, high-dose radiation, or undergoing resection of the pancreatic tumor
- Prior therapy for PDAC
- Prior radiation to the upper abdomen (RT to other sites acceptable)
- Inability to undergo port or PICC line placement
- Active gastric or duodenal ulcer
- Tumor invasion of the intestinal or gastric lumen
- Active hepatitis B or other active serious infections
- Pregnant and breastfeeding women are excluded. Women of child-bearing potential must have a negative urine or serum pregnancy test and be willing to use acceptable methods of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study treatment
- Life expectancy of < 3 months
- Patients with contraindications to either PET scan or MRI (e.g., pacemaker/ICD) will NOT be excluded from study participation. Such patients will be treated per protocol but will not be required to undergo PET-MRI.
Where it is running
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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