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.
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
Early Carcinoma Glottis (T1-T2, N0M0)
Metastatic disease.
Previous radiotherapy to the head and neck region
Lateralised tumours, requiring unilateral irradiation
Parallel
Swallowing and submandibular sparing IMRT
RadiationStandard 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
Radiationstandard IMRT with medical CRT/RT
Cisplatine
DrugCisplatin 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
Change in swallowing function post radiotherapy
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
Swallowing assessment
Swallowing will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.
Aspiration assessment
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.
Acute Toxicity
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
Late Toxicity assessment by RTOG
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
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