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NCT Number: NCT05187091

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 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.

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Key information

Conditions

Head and Neck Neoplasms Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Sparing IMRT

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Early Carcinoma Glottis (T1-T2, N0M0)
  • Metastatic disease.
  • Previous radiotherapy to the head and neck region
  • Lateralised tumours, requiring unilateral irradiation
  • Patients requiring radiation to both submandibular glands
  • Evidence of pre-existing swallowing dysfunction (not related to HNC);
  • Major head and neck surgery (excluding biopsies/tonsillectomy);
  • Tracheostomy placement
  • 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).

Treatment and study plan

Swallowing and submandibular sparing IMRT

Radiation

Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures & submandibular gland sparing by SWOAR-IMRT

Standard IMRT with medical CRT/RT

Radiation

standard IMRT with medical CRT/RT

Cisplatine

Drug

Cisplatin will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease

Primary outcomes

  1. Change in swallowing function post radiotherapy

    Time frame: 6 months

    Primary objective of the SWOAR trial is to determine whether sparing the DARS by SWOAR IMRT, changes swallowing function compared to S- IMRT in advanced HNSCC. The impact of sparing the DARS with SWOAR-IMRT on late swallowing function will be evaluated the MDADI. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. MDADI score ranges from 0-100 where 0 is the worst and 100 is the best score for dysphagia assessment

Secondary outcomes

  1. Swallowing assessment

    Time frame: longitudinal assessment till 2 years

    Swallowing will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.

  2. Aspiration assessment

    Time frame: longitudinal assessment till 2 years

    Longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Patients will be subjected to 10 ml of liquid, semi solid and solid meal at baseline, at completion of CRT/RT, 3, 6, 12 and 24 months.6, 12, and 24 months.

  3. Acute Toxicity

    Time frame: longitudinal assessment till 2 years

    Assessment of acute weekly during radiotherapy as per RTOG

    RTOG grading is from 0 to IV where 0 represents no findings and IV being the worst Findings

  4. Late Toxicity assessment by RTOG

    Time frame: longitudinal assessment till 2 years

    Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as per RTOG score.

    RTOG is from 0 to IV where 0 represents no findings and IV being the worst Findings

  5. Late Toxicity assessment by LENT SOMA

    Time frame: longitudinal assessment till 2 years

    Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as LENT SOMA score.

    LENT SOMA score is from 0 to IV where 0 represents no findings and IV being the worst Findings

  6. Treatment outcome: Loco-regional tumor control

    Time frame: 2 years

    Loco-regional tumor control at 2 years At follow up of 3, 6, 12, and 24 months post treatment

  7. Treatment outcome: Overall survival

    Time frame: 2 years

    Overall survival at 2 years At follow up of 3, 6, 12, and 24 months post treatment

  8. Quality of life assessment: EORTC QLQ C-30

    Time frame: longitudinal assessment till 2 years

    EORTC QLQ C-30 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

    Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  9. Quality of life assessment: EORTC QLQ HN35

    Time frame: longitudinal assessment till 2 years

    As per the EORTC QLQ HN35 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.

Study contacts

Contact information is provided by the study sponsor or research team.

Aman Sharma, MD

CONTACT

[email protected]

+917018529339

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Acronym: SWOAR

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2022
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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