Status:
WITHDRAWN
Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Indiana University
Conditions:
Pancreatic Cancer
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 r...
Detailed Description
Primary Objectives: 1\. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT Secondary Objectives: 1. To assess the following disease ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04130399
Start Date
July 1 2019
End Date
January 1 2023
Last Update
October 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202