April 15 2025
NRG Oncology recently activated a new trial to its genitourinary cancer portfolio. NRG-GU014, also known as the “PARCC” trial is currently accruing patients with high-grade T1 bladder cancer. The trial will be testing if the addition of the immunotherapy drug Pembrolizumab to radiotherapy improves bladder-intact event-free survival for patients when compared to the usual chemotherapy treatment during radiotherapy for this population.
“Currently, treatment options are limited for patients with recurrent high-grade T1 bladder cancer. The prospective results of the RTOG 0926 phase II trial of trimodality therapy as an alternative to radical cystectomy in T1 bladder cancers yielded promise that there were alternative, effective bladder-sparring treatment options; however, a more modern follow-up trial of chemoradiation versus novel combined modality therapies is needed to change clinical practice. This trial was designed to build off the result of RTOG 0926,” stated Brian Baumann, MD, of Springfield Clinic and the Principal Investigator of NRG-GU014.
“NRG GU014 was developed through a clinical trials planning pathway with the input of patient advocates specifically for patients with T1 invasive disease (not muscle invasive) who are being recommended for cystectomy by their treating team. Patients who desire a bladder sparing option will receive either standard chemo radiation therapy or radiation with Pembrolizumab. This immunotherapy drug is already FDA-approved for post-BCG T1 disease with associated carcinoma in situ and has gained signficant interest in the bladder cancer community for combining this drug with radiotherapy,” added Scott Delacroix, MD, of the Mary Bird Perkins Cancer Center and Co-principal investigator of NRG-GU014.
NRG-GU014 will enroll patients with high-risk T1 urothelial carcinoma that were recommended for cystectomy. These patients will be stratified by disease history and histology then randomly assigned to receive either bladder-directed radiotherapy with concurrent chemotherapy (Arm 1) or to receive bladder-directed radiotherapy plus pembrolizumab in 9 cycles (Arm 2).
The primary objective of this study is to compare bladder-intact event-free survival. Secondary aims include assessing complete response by cystoscopy at 6 months, disease-free survival, local-regional control, metastasis-free survival, overall survival, quality of life, and adverse events between treatment arms. The trials also includes exploratory objectives assessing fatigue, quality adjusted survival, and cumulative quality of life at 24 months.
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 and brochure for this study can be found at www.nrgoncology/GU014