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

NCT05187091 | Recruiting Phase 3 DMC

• 1 other identifier: 2021/05/043810
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Neoplasms; Swallowing Sparing IMRT

Keywords

IMRT; Dysphagia; Aspiration; Head and neck cancer; Radiation

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (9)

• Swallowing assessment

  longitudinal assessment till 2 years

• Aspiration assessment

  longitudinal assessment till 2 years

• Acute Toxicity

  longitudinal assessment till 2 years

• Late Toxicity assessment by RTOG

  longitudinal assessment till 2 years

• Late Toxicity assessment by LENT SOMA

  longitudinal assessment till 2 years

Study Arms (2)

Standard IMRT

ACTIVE COMPARATOR

Standard IMRT with radical CRT/RT

Radiation: Standard IMRT with medical CRT/RT; Drug: Cisplatine

Swallowing Sparing IMRT

EXPERIMENTAL

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

Radiation: Swallowing and submandibular sparing IMRT; Drug: Cisplatine

Interventions

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

Standard IMRT; Swallowing Sparing IMRT

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

Swallowing Sparing IMRT

Standard IMRT with medical CRT/RT RADIATION

standard IMRT with medical CRT/RT

Standard IMRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Nci, Aiims

Jhajjar, Haryana, 124105, India

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Interventions

Deglutition

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Aman Sharma, MD

CONTACT

+917018529339; amans757@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: January 11, 2022
• Study Start: July 12, 2021
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)