August 07 2020
NRG-HN006: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
The NRG-HN006 clinical trial opened in July 2020 will be comparing sentinel lymph node (SLN) biopsy treatment to standard neck dissection. This trial aims to determine if SLN biopsy can improve neck and shoulder function and show similar disease-free survival or potentially improve disease-free survival for patients with early-stage oral cavity cancer (T1-2N0). Currently, this patient population is treated with the standard neck dissection which surgically removes the lymph nodes from the neck because of a 20-30% chance of clinically and radiographically undetected metastases. Following surgery, some patients may receive either radiotherapy alone or a combination of radiotherapy and chemotherapy.
While standard neck dissection has demonstrated the ability to lengthen overall survival or time without disease in patients with oral cavity cancer, NRG-HN006 is designed to determine if SLN biopsy could produce similar or better survival results, but superior neck and shoulder function, considering the procedure could be less invasive than the standard of care for patients. Before, during, and following the treatment, researchers will be collecting patient-reported outcome data to determine the effects of the surgical procedures on the trial participants’ quality of life. Secondary objectives for the trial are to determine patterns of failure, compare overall survival and toxicity between treatment arms, measure longitudinal patient-reported neck and shoulder function related to quality of life, assess the length of hospitalization post-operation and understand the role of PET/CT scans in early-stage oral cavity cancer. This study aims to accrue 228 in the phase 2 and 618 patients overall.
“The standard neck dissection treatment, while effective, is a very involved and invasive surgery for patients to undergo that may require an extended period of recovery and has the potential for long-term negative impacts on neck and shoulder pain. Our goal in NRG-HN006 is to assess if SLN biopsy is a similarly effective treatment that is less invasive, more cost effective, and capable of potentially improving quality of life following the procedure,” stated Stephen Y. Lai, MD, PhD of the University of Texas MD Anderson Cancer Center and the Study Chair for NRG-HN006.
Learn more about this trial on ClinicalTrials.gov
Access the protocol documents and materials on CTSU.org