January 14 2025
In December, NRG Oncology activated the NRG-CC013 clinical study to patients with head and neck squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity. This phase 2 trial will compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo. SOM will be defined as Grade >3 mucositis per WHO criteria from the start of chemoradiation, through 4 weeks after completion of study treatment. Additionally, assessments will occur at 6, 8, and 12 weeks after completion of the study.
“Mucositis from radiotherapy occurs in almost all head and neck cancer patients receiving radiotherapy and there is a peak of severity within weeks after radiation treatment. Additionally, these symptoms and their duration are exacerbated by the addition of chemotherapy,” stated David M. Brizel, MD, of the Duke Cancer Institute and the Co-Principal Investigator of the NRG-CC013 clinical study.
“There is urgent and unmet need to identify a radioprotector in this setting that can improve the quality of life for patients and reduce the treatment breaks, nutritional deficits, and feeding tube requirements that are caused by mucositis in these patients,” added Sue S. Yom, MD, PhD of the University of California, San Francisco and the Co-Principal Investigator of the NRG-CC013 clinical study.
Following enrollment, eligible patients will be stratified by ipsilateral or bilateral neck irradiation and HPV status. Patients on the trial will then be randomly assigned to one of two potential treatment arms. Treatment allocation will be masked to investigators and patients. Patients on both treatment arms will receive the usual symptom management for chemoradiation. Additionally, patients on treatment arm 1 will receive a concurrent placebo versus patients on treatment arm 2 who will receive concurrent BMX-001.
In addition to the primary objective of comparing incidence of SOM between treatment arms, the secondary objectives of NRG-CC013 include comparing the duration of SOM, assessing the differences in OMWQ-HN change scores from baseline to 4 weeks following chemoradiation, describing the incidence and severity of xerostomia and radiation dermatitis, comparing the duration of radiation dermatitis, and describing overall toxicity between treatment arms.
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 can be found at www.nrgoncology.org/CC013