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

Last updated: January 17, 2022
Sponsor: All India Institute of Medical Sciences, New Delhi
Overall Status: Active - Recruiting

Phase

3

Condition

Head And Neck Cancer

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT05187091
2021/05/043810
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 carcinomarequiring bilateral neck radiotherapy and where sparing of contra lateral or onesubmandibular gland is possible
  4. Radiotherapy with concomitant chemotherapy (unless contraindicated) is the plannedtreatment
  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 oflife 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

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 interferewith completion of therapy, trial assessments or follow-up
  10. Any invasive malignancy within previous 2 years (other than non melanomatous skincarcinoma or cervical carcinoma in situ).

Study Design

Total Participants: 136
Study Start date:
July 11, 2021
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Nci, Aiims

    Jhajjar, Haryana 124105
    India

    Active - Recruiting

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