Balancing Minimally Invasive Surgery with Patient Quality of Life

The ExteNT N0 clinical trial, led by the Kolhapur Cancer Centre (KCC) in India, represents a pioneering effort to optimize surgical approaches for patients with clinically node-negative (cN0) oral squamous cell carcinoma (OSCC). The current standard of care involves selective neck dissection (SND), removing lymph node levels I-III, to prevent metastasis. However, the global head and neck surgery community continues to debate whether the dissection range should be extended to level IV. This study, which began recruiting patients on April 22, 2026, focuses on minimizing unnecessary dissection to prevent postoperative complications. This approach addresses the clinical need to minimize surgical trauma while maintaining oncological stability.

Demonstrating Non-Inferiority Through Key Evaluation Indicators

The research team is conducting a head-to-head comparison of outcomes in 267 patients randomly assigned in a 1:1 ratio to either level I-III dissection or level I-IV dissection. The primary endpoint is regional recurrence-free survival (RRFS) at 3 years post-surgery, aiming to demonstrate non-inferiority by showing that reducing the surgical range does not increase the risk of local recurrence. Secondary endpoints include overall survival (OS), disease-free survival (DFS), and occult nodal metastasis rate, which will be tracked to provide a comprehensive assessment. If level I-III dissection proves sufficient for cancer control, it could establish a new standard of care for oral cancer surgery.

Comprehensive Evaluation of Reduced Side Effects and Preserved Shoulder Function

Another key objective of this study is to alleviate potential complications associated with extensive lymph node dissection, such as shoulder dysfunction and pain. Extending the surgical dissection to level IV can stimulate major nerves and muscles in the neck, potentially leading to significant physical impairment. To quantitatively measure this, the researchers will use the Constant-Murley Score and the Shoulder Pain and Disability Index (SPADI) to assess patient recovery over 24 months post-surgery. Additionally, the Neck Dissection Impairment Index (NDII), a patient-reported outcome measure, will be used to demonstrate the extent of improvement in patients' daily lives.

Prospects for Transforming the Global Paradigm of Oral Cancer Treatment

This clinical trial is scheduled for completion in September 2030 and will consider standard anti-cancer treatment protocols, including radiotherapy or chemoradiotherapy, based on the final pathology results after surgery. Reducing the surgical dissection range not only alleviates physical discomfort for patients but also reduces surgical costs and rehabilitation time, leading to economic benefits. This is expected to raise important issues regarding the efficient allocation of medical resources, particularly in the Asia-Pacific (APAC) region, where oral cancer incidence is high. The results of this multi-center clinical trial have the potential to influence revisions to global standard treatment guidelines, such as those published by the National Comprehensive Cancer Network (NCCN).