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Recruiting 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

Phase III Interventional Head and Neck Neoplasms Swallowing Sparing IMRT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Swallowing and submandibular sparing IMRT, Standard IMRT with medical CRT/RT, Cisplatine.
Who it may be relevant to
Registry conditions: Head and Neck Neoplasms, Swallowing Sparing IMRT. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Radiation Swallowing and submandibular sparing IMRT
    Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures \& submandibular gland sparing by SWOAR-IMRT
  • Radiation Standard IMRT with medical CRT/RT
    standard IMRT with medical CRT/RT
  • Drug Cisplatine
    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 outcome measures

  • Change in swallowing function post radiotherapy [Time frame: 6 months]
Secondary outcome measures (9)
  • Swallowing assessment [Time frame: longitudinal assessment till 2 years]
  • Aspiration assessment [Time frame: longitudinal assessment till 2 years]
  • Acute Toxicity [Time frame: longitudinal assessment till 2 years]
  • Late Toxicity assessment by RTOG [Time frame: longitudinal assessment till 2 years]
  • Late Toxicity assessment by LENT SOMA [Time frame: longitudinal assessment till 2 years]
  • Treatment outcome: Loco-regional tumor control [Time frame: 2 years]
  • Treatment outcome: Overall survival [Time frame: 2 years]
  • Quality of life assessment: EORTC QLQ C-30 [Time frame: longitudinal assessment till 2 years]
  • Quality of life assessment: EORTC QLQ HN35 [Time frame: longitudinal assessment till 2 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Nci, Aiims — Jhajjar

Identifiers

NCT: NCT05187091 · 2021/05/043810

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗