NCT05187091RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 18 Aug 2021
- Start date
- 12 Jul 2021
- Primary completion date
- 12 Aug 2026
- Lead sponsor
- All India Institute of Medical Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT05187091
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 136
- From 12 Jul 2021 to the primary completion date, 12 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Metastatic disease.
Other
- Early Carcinoma Glottis (T1-T2, N0M0)
- Evidence of pre-existing swallowing dysfunction (not related to HNC);
- Tracheostomy placement
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nci, Aiims Coordinator of this site? Confirm its status | Jhajjar | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.