A Phase IIIII Trial Testing Removal of Radiotherapy to Regional Lymph Nodes in Patients with pN0 or pN1 Oral Cavity Cancer Undergoing Surgery

What this Trial Is About

Researchers are evaluating whether skipping postoperative radiotherapy PORT to regional lymph nodes in patients with oral cavity squamous cell carcinoma OCSCC who have pN0 or pN1 neck status can achieve similar treatment outcomes. This phase IIIII randomized trial focuses on patients who have undergone radical surgery with adequate lymph node dissection and have high-risk features such as positive or close margins, lymphovascular or perineural invasion, or advanced primary tumor stage. The study addresses the uncertain benefits and potential side effects of radiotherapy to regional lymphatics in this group. Participants are randomly assigned to one of two groups one receiving standard PORT to both the primary tumor bed and regional lymphatics, and the other receiving PORT only to the primary tumor bed while omitting radiotherapy to regional lymph nodes. Radiotherapy is delivered as intensity-modulated radiation therapy IMRT at doses of 66Gy33 fractions, 60Gy30 fractions, or 50Gy20 fractions. In cases of positive surgical margins, weekly cisplatin chemotherapy is given during radiotherapy. The trial excludes patients with more extensive nodal disease pN2 or pN3 and those requiring re-irradiation. Participants will be monitored over two years to assess regional control of cancer, local control, disease-free survival, overall survival, and treatment-related toxicities including acute and late side effects. Swallowing function and quality of life are also evaluated through questionnaires. The study requires timely initiation of radiotherapy, completion of specific quality of life tools, and long-term follow-up visits. Safety and effectiveness outcomes will help determine if omitting radiotherapy to regional lymphatics is feasible without compromising cancer control.

A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's