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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

Study acronym: SWOAR
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion pushed from Mar 12, 2025 to Aug 12, 2026
    • Trial status changed: Active, Not Recruiting → Recruiting
    • Start date: Jun 11, 2021 to Jul 12, 2021
    • Site details revised
    v4
  3. Primary completion date changed from estimate of Jun 2023 to Mar 12, 2025v3 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2025 to Dec 2026
    • Start date: Jul 11, 2021 to Jun 11, 2021
    • Interventions: Swallowing and submandibular sparing IMRT (Radiation) to Cisplatine (Drug), Standard IMRT with medical CRT/RT (Radiation), Swallowing and submandibular sparing IMRT (Radiation)
    • Site details revised
  4. Eligibility criteria revised
    • Study title expanded, about 2 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05187091
Lead Sponsor All India Institute of Medical Sciences
Conditions
(from sponsor)		 Head and Neck Neoplasms, Swallowing Sparing IMRT
Related terms Deglutition Disorders, Head and Neck Neoplasms
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov