Head and Neck NeoplasmsPhase 3SWOARNCT05187091
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
A Phase 3 study testing Swallowing and submandibular sparing IMRT, Standard IMRT with medical CRT/RT and Cisplatine in people with Head and Neck Neoplasms and Swallowing Sparing IMRT, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Neoplasms, Swallowing Sparing IMRT
- What is being tested?
- Swallowing and submandibular sparing IMRT, Standard IMRT with medical CRT/RT and Cisplatine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jul 2021to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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);
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Nci, Aiims
Jhajjar, Haryana, 124105
Aman Sharma, MD, +917018529339, amans757@gmail.com
About this study
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
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.
Read more
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
- Being tested
- Swallowing and submandibular sparing IMRT, Standard IMRT with medical CRT/RT, Cisplatine
- Keywords
- IMRT, Dysphagia, Aspiration, Head and neck cancer, Radiation
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing and submandibular sparing IMRTRadiation
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures \& submandibular gland sparing by SWOAR-IMRT
Standard IMRT with medical CRT/RTRadiation
standard IMRT with medical CRT/RT
CisplatineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Standard IMRT | Active comparator | Standard IMRT with radical CRT/RT Receives: 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 Receives: Radiation: Swallowing and submandibular sparing IMRT; Drug: Cisplatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
Swallowing assessment
Swallowing will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.
Measured: longitudinal assessment till 2 years
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.
Measured: longitudinal assessment till 2 years
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
Measured: longitudinal assessment till 2 years
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
Measured: longitudinal assessment till 2 years
Late Toxicity assessment by LENT SOMA
Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as LENT SOMA score.
LENT SOMA score is from 0 to IV where 0 represents no findings and IV being the worst Findings
Measured: longitudinal assessment till 2 years
Treatment outcome: Loco-regional tumor control
Loco-regional tumor control at 2 years At follow up of 3, 6, 12, and 24 months post treatment
Measured: 2 years
Treatment outcome: Overall survival
Overall survival at 2 years At follow up of 3, 6, 12, and 24 months post treatment
Measured: 2 years
Quality of life assessment: EORTC QLQ C-30
EORTC QLQ C-30 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: longitudinal assessment till 2 years
Quality of life assessment: EORTC QLQ HN35
As per the EORTC QLQ HN35 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H\&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
Measured: longitudinal assessment till 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start12 Jul 2021
- Primary completion12 Aug 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aman Sharma, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187091
- Sponsor's protocol ID
- 2021/05/043810
- Acronym
- SWOAR
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05187091
- Acronym / sponsor ID
- SWOAR / 2021/05/043810
- Conditions
- Head and Neck Neoplasms, Swallowing Sparing IMRT
- Keywords
- IMRT, Dysphagia, Aspiration, Head and neck cancer, Radiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard IMRT | Active comparator | Radiation: Standard IMRT with medical CRT/RT, Drug: CisplatineStandard IMRT with radical CRT/RT |
| Swallowing Sparing IMRT | Experimental | Radiation: Swallowing and submandibular sparing IMRT, Drug: CisplatineStandard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures \& submandibular gland sparing by SWOAR-IMRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowing and submandibular sparing IMRTStandard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures \& submandibular gland sparing by SWOAR-IMRT | Radiation | Swallowing Sparing IMRT |
| Standard IMRT with medical CRT/RTstandard IMRT with medical CRT/RT | Radiation | Standard IMRT |
| CisplatineCisplatin 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 | Drug | Standard IMRT, Swallowing Sparing IMRT |
Primary outcome
Change in swallowing function post radiotherapy
Time frame: 6 months
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Swallowing and submandibular sparing IMRT, Standard IMRT with medical CRT/RT and Cisplatine in people with Head and Neck Neoplasms and Swallowing Sparing IMRT, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aman Sharma, MD (+917018529339, amans757@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in swallowing function post radiotherapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.