April 14 2021
Testing if Sentinel Lymph Node Biopsy has Acceptable Cancer Control and Improves Quality of Life for People with Early-Stage Oral Cavity Cancer (NRG-HN006)
*Currently Enrolling Patients*
NRG-HN006: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
The randomized Phase II/III NRG-HN006 trial will be comparing sentinel lymph node (SLN) biopsy to the standard of care surgical procedure, elective neck dissection (END), for patients who have early-stage oral cavity cancer. END is a surgical procedure that removes a large number of the lymph nodes in the neck while preserving normal tissues. The issue with this surgical procedure is that it removes lymph nodes, regardless of whether or not the node is impacted by cancer, thus exposing treated patients to a higher risk of potentially morbidity-related quality of life issues, including decreased shoulder and neck mobility and strength. As head and neck cancer is among the most common malignancies globally (Vigneswaran 2014) and oral cavity cancer represents the leading form of this type of cancer, it is imperative that researchers focus on improving the quality of life and outcomes for these patients following their treatments.
NRG-HN006 study leaders hypothesize that SLN biopsy treatment lead to acceptable cancer control and help decrease the burden on patient quality of life in this population when compared to END treatment. SLN biopsy requires injection around the patient’s primary tumor of a radiotracer that travels along the lymphatic channels to the cervical lymph nodes and to facilitate biopsy of thoselymph nodes which are most likely to be impacted by disease. This mapping procedure allows surgeons to focus on removing only the highest “at risk” nodes via small incisions at the time of removing the primary tumor. The lack of surgical manipulation could decrease the issues associated with shoulder and neck mobility and strength.
“Of these patients that receive END treatment, approximately 70-80% do not have cancer in their lymph nodes, but all of the lymph nodes are removed to avoid the risk of the cancer recurring. Our research team wants to determine if there is a better way to treat patients that involves less invasive surgical techniques and improves their quality of life than our current standard of care. We also would like to see if SLN biopsy could also potentially be more cost effective and involve less or equal hospitalization or recovery time for our patients,” stated Stephen Y. Lai, MD, PhD, FACS, of the University of Texas MD Anderson Cancer Center and the Principal Investigator of the NRG-HN006 trial.
The Phase II portion of this trial will enroll 228 patients and will primarily observe patient-reported neck and shoulder function and related quality of life measures at 6 months following their surgical procedure in both the END and SLN biopsy treatment groups. Next, the Phase III portion of this trial will be additionally comparing disease-free survival between surgical arms in 618 enrolled patients, including the participants from the Phase II portion of the study. Secondary aims of NRG-HN006 are to compare patterns of failure, overall survival, toxicity, longitudinal patient-reported neck and shoulder function and related quality of life outcomes, length of hospitalization, post-operative drain placement, operative morbidity, and nodal metastases rates between surgical arms.
Trial participants with proven early-stage oral cavity cancer will be registered to the trial and will receive a PET/CT scan. After their registration and imaging scans, patients who have a negative PET/CT scan confirmed by a central read will be stratified by their Clinical and Radiologic T-stage as well as their Zubrod Performance Status. These patients will then be randomly assigned to receive the SLN biopsy treatment or the END treatment. Participants with a positive PET/CT scan will have their neck pathology findings recording in a registry, but will be required to go off the study (no additional follow up).
Patients have been enrolled to the study at this point (Step 1 registration only).
Learn more about this trial on ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website.
Citation
Vigneswaran N, Williams MD. Epidemiologic trends in head and neck cancer and aids in diagnosis. Oral Maxillofac Surg Clin North Am. 2014;26(2): 123-141. (PMID: 24794262)