Tests a swallow-sparing radiation plan in head and neck cancer
Tests radiation that spares swallowing organs in people with head and neck cancer.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Jhajjar, IndiaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05187091, who can take part
Where in India
- Nci, AiimsJhajjar, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- All India Institute of Medical Sciences
- Trial code
- NCT05187091
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
The SWOAR Trial: A Phase III Trial Evaluating 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
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.
Inclusion: Aged 18 or above and less than 70 years; Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx; Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible; Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment; Karnofsky performance score greater or equal 70; Available to attend long term follow- up; Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version; Willingness to undergo FEES; Written informed consent for treatment; Available to attend long term follow- up.
Exclusion: Previous radiotherapy to the head and neck region; Lateralised tumours, requiring unilateral irradiation; Patients requiring radiation to both submandibular glands; Major head and neck surgery (excluding biopsies/tonsillectomy); Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up; Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ); Metastatic disease; Early Carcinoma Glottis (T1-T2, N0M0); Evidence of pre-existing swallowing dysfunction (not related to HNC); Tracheostomy placement.