NRG Oncology opens new “ARCHER” clinical trial (NRG-GU015) testing a shorter treatment duration of radiation therapy for muscle invasive bladder cancer

(Press-News.org) 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 tumor (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 specialized centers 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 center is highly attractive to patients and their families,” stated Scott Delacroix, MD, at the Mary Bird Perkins Cancer Center 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 Center 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 utilize integrated biomarker circulating tumor 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.

More information regarding this study can be found on ClinicalTrials.gov and protocol documents are available by logging into CTSU.org.

 

About NRG Oncology

NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on sex-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network. www.nrgoncology.org

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