July 15 2025
NRG Oncology recently activated the NRG-GI011 trial, also known (LAP100). This Phase III randomized controlled trial will assess the role of dose-escalated radiotherapy (target biologic effective dose of 100 Gy, hence name LAP100) in locally advanced pancreatic cancer.
“Smaller, single-arm studies have suggested a benefit for the addition of dose-escalated radiotherapy in locally advanced (unresectable) pancreas cancer, but the regimen has not been tested in a randomized fashion at the national, cooperative group level. If the trial is positive, this would establish a new standard of care in locally advanced pancreas cancer, a disease site and setting in great need of better treatments. We are grateful to NRG, the NCI, and the NIH for supporting this trial,” stated Nina Sanford, MD, of the University of Texas Southwestern Department of Radiation Oncology and Principal Investigator of NRG-GI011.
Patients on this study will need to have received an initial 4-6 months of chemotherapy with FOLFIRIINOX, NALIRIFOX, or gemcitabine/nab-paclitaxel, which are standard of care chemotherapy regimens for pancreas cancer. After, they are required to have restaging scans showing no radiographic progression, and a drop in CA19-9 by 50% or to within normal range, with absolute value less than 100 u/mL. After enrollment onto the trial, they will be randomized 1:1 to either 1) dose-escalated radiotherapy (experimental treatment) or 2) standard of care treatments including additional chemotherapy, “standard” dose chemoradiation, or observation, at the discretion of the treating physician. Experimental treatment consists of dose-escalated radiotherapy with target biologic effective dose (BED) of 100 Gy via a 5- or 25-fraction regimen. Investigators are encouraged to use the 5-fraction regimen when feasible.
The target accrual for the LAP100 study is 356 patients. The primary aim of this study is to determine if dose-escalated radiotherapy improves 3-year overall survival when compared to the usual treatment for patients with locally advanced pancreatic cancer. The trial is also powered to detect an improvement in health-related quality-of life. Secondary objectives include evaluating and comparing local progression, progression-free survival, chemotherapy-free interval, and toxicity between the two treatment arms. Biospecimens will also be collected for future correlative analyses.
Please consider enrolling onto this trial, and reach out with any questions!
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website
The patient study webpage for this trial is located at www.nrgoncology.org/GI011