Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)
Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant
treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment
pancreatic tumor tissues will be collected and immediately frozen at the time of staging
endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens
and run on microarray analysis to determine radiosensitivity index score. Borderline
resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT.
They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic
patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Margin-negative (R0) Resection Rate
The primary endpoint is correlation of a radiosensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response); R1 (Moderate Response); R2 (Minimal Response); R3 (No Response).
Ravi Shridhar, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|