Actively Recruiting
Phase III Trial Comparing Swallowing and Aspiration Organ Sparing IMRT Versus Standard IMRT for Head and Neck Squamous Cell Carcinomas of the Oropharynx, Larynx, and Hypopharynx
Led by All India Institute of Medical Sciences · Updated on 2026-05-04
136
Participants Needed
1
Research Sites
15 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new radiation therapy approach called Swallowing and Submandibular Sparing Intensity Modulated Radiotherapy SWOAR IMRT for patients with head and neck squamous cell carcinomas HNSCC of the oropharynx, larynx, and hypopharynx. This phase III trial compares SWOAR IMRT with standard intensity modulated radiotherapy IMRT to see if sparing certain swallowing and aspiration-related structures, as well as one submandibular gland, can reduce swallowing difficulties and aspiration risks. The study also tracks tumor control and survival outcomes over time. Participants receive either standard IMRT combined with radical concurrent chemoradiotherapy or SWOAR IMRT, which adds protection to specific swallowing-related organs and a submandibular gland during radiation treatment. Cisplatin chemotherapy is given weekly during radiation at a dose of 40 mgm2, aiming for a cumulative dose of at least 200 mgm2 if there is margin-positive disease. Treatment is provided according to random assignment, and patients are monitored closely throughout therapy. During the study, swallowing function is assessed using the MD Anderson Dysphagia Inventory MDADI at baseline, treatment completion, and multiple points up to 24 months after radiotherapy. Aspiration risk is evaluated with a swallowing endoscopic exam FEES using a penetration-aspiration score. Acute and late treatment side effects are recorded weekly during therapy and at follow-ups. Tumor recurrence and overall survival are tracked for up to five years. Quality of life is also measured with standardized questionnaires. Participants will be followed for long-term safety and treatment effects.
CONDITIONS
Brief Title
The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas
Research Team
A
Aman Sharma, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
