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
Recruiting
Phase 3
Interventional Study
Head and Neck Neoplasms
Swallowing Sparing IMRT
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 136 (estimated)
- Sponsor
- All India Institute of Medical Sciences · Other
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About This Trial
The aim of SWOAR TRIAL is to test sparing of Dysphagia/ Aspiration risk structures (DARS) and contra lateral submandibular gland by IMRT. HNSCC of the oropharynx, larynx and the hypopharynx treated with radical concurrent chemoradiotherapy or radiotherapy will be included in the trial. Patients will be randomized to SWOAR IMRT or standard IMRT.
Swallowing function will be evaluated the MD Anderso…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Aged 18 or above and less than 70 years
2. Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx.
3. Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of co…
Contacts