NRG Oncology (NRG), a National Cancer Institute (NCI) National Clinical Trials Network (NCTN) group focused on improving outcomes for adult cancers, recently opened a new clinical trial “ARCHER” (NRG-GU015) to study a shorter duration of radiation therapy for patients with muscle invasive bladder cancer.

“A quarter of all bladder cancers in the United States are muscle-invasive bladder cancers. Currently, the standard of care treatment for this disease consists of either (1) bladder preservation with transurethral resection of bladder tumour (TURBT), chemotherapy, and radiation; or (2) neoadjuvant chemotherapy and surgical removal of the bladder (cystectomy). These two pathways of treatment have comparable survival rates and both are considered standard of care in this disease. Although very different from patient’s perspective, both treatment options require frequent visits to specialised centres over several months. Up to 20% of the patients with muscle invasive bladder cancer do not receive one of these curative intent treatments because of logistical concerns. Reducing the burden of frequent travel to the radiation centre is highly attractive to patients and their families,” stated Scott Delacroix, MD, at the Mary Bird Perkins Cancer Centre and the Principal Investigator of the ARCHER study.

The primary objective of the ARCHER is to determine whether an ultra-hypofractionated delivery of stereotactic body radiation therapy (SBRT) is non-inferior to hypofractionated radiotherapy with regards to bladder-intact event-free survival at 3 years. Patients will be randomly assigned to either receive 4 weeks of daily hypofractionated radiotherapy (55 Gy in 20 fractions) or 5 days of ultra-hypofractionated SBRT (32.5 Gy in 5 fractions) over 4 weeks.

“If we can safely reduce the number of treatments without sacrificing bladder preservation rate, we can meaningfully reduce patient burden—fewer visits, lower cumulative toxicity, and less financial and psychosocial stress—and ultimately improve quality of life.,” added Himanshu Nagar, MD, MS, at the Memorial Sloan Kettering Cancer Centre and Co-Principal Investigator of the ARCHER study.

“The translational components built into this trial will help guide the future care of our patients and next generation of trials. The study team will collect and utilise integrated biomarker circulating tumour DNA (ctDNA) data as a predefined secondary endpoint to define further the role of ctDNA for predicting disease recurrence in the context of muscle invasive bladder cancer,“ stated Catherine Spina MD PhD at Columbia University and co-Chair for Translational Science for NRG-GU015.

Secondary objectives of this study include comparisons of the rates of urinary and bowel toxicity, patient reported outcomes, event-free survival, metastasis-free survival, overall survival, symptomatic adverse events, and quality of life measures that are most meaningful to patients between the two treatment arms.This study will also explore and evaluate additional biomarkers for predicting recurrence and outcomes.

Source: NRG Oncology