Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Swallowing Sparing IMRT
Keywords: IMRT
Dysphagia
Aspiration
Head and neck cancer
Radiation
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible
4. Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment
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 of life 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 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 interfere with completion of therapy, trial assessments or follow-up
10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).

Primary outcomes:
measure: Change in swallowing function post radiotherapy
timeFrame: 6 months
Secondary outcomes:
measure: Swallowing assessment
timeFrame: longitudinal assessment till 2 years
measure: Aspiration assessment
timeFrame: longitudinal assessment till 2 years
measure: Acute Toxicity
timeFrame: longitudinal assessment till 2 years
measure: Late Toxicity assessment by RTOG
timeFrame: longitudinal assessment till 2 years
measure: Late Toxicity assessment by LENT SOMA
timeFrame: longitudinal assessment till 2 years
measure: Treatment outcome: Loco-regional tumor control
timeFrame: 2 years
measure: Treatment outcome: Overall survival
timeFrame: 2 years
measure: Quality of life assessment: EORTC QLQ C-30
timeFrame: longitudinal assessment till 2 years
measure: Quality of life assessment: EORTC QLQ HN35
timeFrame: longitudinal assessment till 2 years
Other outcomes:
Locations:
city: Jhajjar
country: India
facility: Nci, Aiims
state: Haryana
Study officials:
References: