Actively Recruiting
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
Led by All India Institute of Medical Sciences · Updated on 2026-05-04
136
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Anderson Dysphagia Inventory (MDADI) scoring. 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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or above and less than 70 years
- Diagnosed with head and neck squamous cell carcinoma of the oropharynx, larynx, or hypopharynx
- Stage T1-4, N0-3, M0 disease requiring bilateral neck radiotherapy and possible sparing of the contralateral or one submandibular gland
- Planned treatment with radiotherapy and concomitant chemotherapy unless contraindicated
- Karnofsky performance score of 70 or higher
- Able to attend long-term follow-up visits
- Able to complete MD Anderson Dysphagia Inventory and EORTC quality of life questionnaires in English or Hindi
- Willing to undergo Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
- Provided written informed consent for treatment
You will not qualify if you...
- Early carcinoma glottis (T1-T2, N0M0)
- Metastatic disease
- Previous radiotherapy to the head and neck region
- Lateralised tumors requiring unilateral irradiation
- Radiation needed to both submandibular glands
- Pre-existing swallowing dysfunction unrelated to head and neck cancer
- Major head and neck surgery excluding biopsies or tonsillectomy
- Presence of tracheostomy
- Any illness interfering with therapy completion, trial assessments, or follow-up as judged by investigator
- Any invasive malignancy within the previous 2 years except non-melanomatous skin carcinoma or cervical carcinoma in situ
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nci, Aiims
Jhajjar, Haryana, India, 124105
Actively Recruiting
Research Team
A
Aman Sharma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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