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 (SWOAR)
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.
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Aman Sharma, MD
- Número de telefone: +917018529339
- E-mail: amans757@gmail.com
Locais de estudo
-
-
Haryana
-
Jhajjar, Haryana, Índia, 124105
- Recrutamento
- Nci, Aiims
-
Contato:
- Aman Sharma, MD
- Número de telefone: +917018529339
- E-mail: amans757@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Standard IMRT
Standard IMRT with radical CRT/RT
|
|
|
Experimental: Swallowing Sparing IMRT
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures & submandibular gland sparing by SWOAR-IMRT
|
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures & submandibular gland sparing by SWOAR-IMRT
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in swallowing function post radiotherapy
Prazo: 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
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Swallowing assessment
Prazo: longitudinal assessment till 2 years
|
Swallowing will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.
|
longitudinal assessment till 2 years
|
|
Aspiration assessment
Prazo: longitudinal assessment till 2 years
|
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.
|
longitudinal assessment till 2 years
|
|
Acute Toxicity
Prazo: longitudinal assessment till 2 years
|
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 |
longitudinal assessment till 2 years
|
|
Late Toxicity assessment by RTOG
Prazo: longitudinal assessment till 2 years
|
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 |
longitudinal assessment till 2 years
|
|
Late Toxicity assessment by LENT SOMA
Prazo: longitudinal assessment till 2 years
|
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 |
longitudinal assessment till 2 years
|
|
Treatment outcome: Loco-regional tumor control
Prazo: 2 years
|
Loco-regional tumor control at 2 years At follow up of 3, 6, 12, and 24 months post treatment
|
2 years
|
|
Treatment outcome: Overall survival
Prazo: 2 years
|
Overall survival at 2 years At follow up of 3, 6, 12, and 24 months post treatment
|
2 years
|
|
Quality of life assessment: EORTC QLQ C-30
Prazo: longitudinal assessment till 2 years
|
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. |
longitudinal assessment till 2 years
|
|
Quality of life assessment: EORTC QLQ HN35
Prazo: longitudinal assessment till 2 years
|
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.
|
longitudinal assessment till 2 years
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021/05/043810
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .