Dr Hall on Addressing Unanswered Questions in Rectal Cancer Treatment Through the JANUS Trial

“Which patients will achieve a durable, long-term clinical complete response, meaning no cancer on endoscopy and no cancer on MRI. How do we know that before we start the cancer treatment? These are absolutely essential questions.”

William A. Hall, MD, a professor in and the chair of radiation oncology, the medical director of Froedtert Radiation Oncology, and the Bob Uecker Endowed Chair, Department of Surgery, School of Graduate Studies, at the Medical College of Wisconsin, discussed notable remaining questions in rectal cancer that the phase 2/3 Janus Rectal Cancer Trial (NCT05610163) will aim to answer.

Hall stated that a key unmet need in the field is the ability to identify, prior to treatment initiation, which patients are likely to achieve a clinical complete response. Additionally, investigators are looking to identify signals throughout the course of neoadjuvant treatment with a high degree of sensitivity and specificity which can inform which patients will not require surgery, he added. The Janus Rectal Cancer Trial will allow for the potential identification of multi-omic biomarkers that could be quickly integrated into the treatment paradigm, he noted.

The Janus Rectal Cancer Trial is a 2-arm, national, randomized study that will investigate effect of long-course chemoradiation followed by either triplet or doublet chemotherapy in patients with locally advanced rectal cancer. The primary end points are clinical complete response and disease-free survival. Secondary end points include organ-preservation time, time to distant metastasis, overall survival, and the rate of adverse effects. Circulating tumor DNA status will be evaluated as an exploratory end point.

Disclosures: Hall reported having stock and other ownership interests in Sonoptima; he holds consulting or advisory roles with Aktis Oncology and Sonoptima. He received institutional research funding as well as travel, accommodations, and expenses from Elekta. He has a patent pending for a wearable device for radiation treatment planning.