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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

RecruitingPhase 3Ages 18 Years - 70 YearsAllAll India Institute of Medical Sciences
NCT05187091 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 or above and less than 70 years 2. Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx. 3. 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 4. Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment 5. Karnofsky performance score greater or equal 70 6. Available to attend long term follow- up; 7. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version. 8. Willingness to undergo FEES. 9. Written informed consent for treatment. 10. Available to attend long term follow- up Exclusion Criteria: 1. Early Carcinoma Glottis (T1-T2, N0M0) 2. Metastatic disease. 3. Previous radiotherapy to the head and neck region 4. Lateralised tumours, requiring unilateral irradiation 5. Patients requiring radiation to both submandibular glands 6. Evidence of pre-existing swallowing dysfunction (not related to HNC); 7. Major head and neck surgery (excluding biopsies/tonsillectomy); 8. Tracheostomy placement 9. Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up 10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
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What it tests

  • Swallowing and submandibular sparing IMRT
  • Standard IMRT with medical CRT/RT
  • Cisplatine
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Where

1 site
Nci, Aiims
Jhajjar, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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