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Clinical Trial Summary

The aim of this study is to test the potential of IMRT in sparing of Dysphagia/ Aspiration risk structures and contra lateral submandibular gland in HNSCC of the oropharynx, larynx and the hypopharynx after radical concurrent chemoradiotherapy or radiotherapy. Primary objective of the SWOAR trial is to determine whether sparing the dysphagia aspiration-related structures (DARS) by IMRT (SWOAR IMRT) improves swallowing function compared to Standar IMRT (S- IMRT) in advanced HNSCC. The impact of sparing the DARS with SWOAR-IMRT on late swallowing function will be evaluated the MDADI. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. Secondary Objectives include longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Swallowing function, will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months. Assessment of acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, and 24 months post treatment as per RTOG and LENT SOMA score, respectively. Treatment outcomes will be assessed in terms of loco-regional tumor recurrence and overall survival, assessed at follow-up visits 3, 6, 12, and 24 months post treatment and then annually until 5 years post treatment.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05187091
Study type Interventional
Source All India Institute of Medical Sciences, New Delhi
Contact Aman Sharma, MD
Phone +917018529339
Email [email protected]
Status Recruiting
Phase Phase 3
Start date July 11, 2021
Completion date June 2025

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