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
NCT ID: NCT05187091
Last Updated: 2022-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
136 participants
INTERVENTIONAL
2021-07-11
2025-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard IMRT
Standard IMRT with radical CRT/RT
No interventions assigned to this group
Swallowing Sparing IMRT
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures \& submandibular gland sparing by SWOAR-IMRT
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
70 Years
ALL
Yes
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Aman Sharma
Assistant Professor
Locations
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Nci, Aiims
Jhajjar, Haryana, India
Countries
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Central Contacts
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Facility Contacts
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Aman Sharma, MD
Role: primary
Other Identifiers
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2021/05/043810
Identifier Type: -
Identifier Source: org_study_id