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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-70 lat
- •Rak gardła, krtani lub gardła dolnego potwierdzony badaniem histologicznym
- •Stan ogólny pozwalający na leczenie (Karnofsky ≥70 punktów)
- •Planowana radioterapia łącznie z chemioterapią
- •Możliwość regularnych wizyt kontrolnych przez 2 lata
- •Zdolność do wypełniania kwestionariuszy dotyczących połykania i jakości życia
- •Zgoda na badanie endoskopowe połykania
- •Podpisana świadoma zgoda na uczestnictwo
✗ Disqualifies
- •Wczesny rak krtani (stadium T1-T2, N0M0)
- •Przerzuty nowotworowe na odległość
- •Poprzednia radioterapia głowy i szyi
- •Zaawansowane zaburzenia połykania przed rozpoczęciem leczenia
- •Duże zabiegi chirurgiczne na głowie lub szyi (z wyjątkiem biopsji)
- •Obecność канюли tracheotomijnej
- •Inny nowotwór w ciągu ostatnich 2 lat
- •Pacjenci wymagający napromieniania obu gruczołów ślinowych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- September 11, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Nci, Aiims
Jhajjar, India
Trial contact
Aman Sharma, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/12/2026.
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