Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
DAHANCA Proton Feasibility Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale and/or xerostomia >= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP).
At least five patients from each of the six Danish centers are required in this feasibility study.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Aalborg, Dinamarca
- Aalborg University Hospital
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Aarhus, Dinamarca
- Aarhus University Hospital
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Aarhus, Dinamarca
- Danish Center for Particle Therapy
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Copenhagen, Dinamarca
- Rigshospitalet
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Herlev, Dinamarca
- Herlev Hospital
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Næstved, Dinamarca
- Næstved Hospital
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Odense, Dinamarca
- Odense University Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent
A predicted clinical significant reduction in the risk of any of the two primary endpoints (>= grade 2 observer-rated dysphagia or grade 2 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans
No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer
Informed consent as required by law
Above 18 years of age
Exclusion Criteria:
Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, nasopharynx, unknown primary tumor and prior malignancies.
Patients with contraindications for proton therapy (as per 2019 pacemakers, implanted defibrillators and tracheostomy)
Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
Distant metastasis
Previous radiotherapy of the head and neck
Previous surgery for the primary cancer with curative intent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Proton radiotherapy
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W,with cisplatin 40 mg/m2/W and nimorazole to suitable patients
|
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Disfagia >= grau 2
Prazo: Seis meses após o término da radioterapia
|
A taxa de disfagia relatada pelo observador >= grau 2 medida pelo escore de toxicidade tardia DAHANCA (grau 0-4, sendo 0 o melhor)
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Seis meses após o término da radioterapia
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|
Xerostomia = grade 2
Prazo: Six months after end of radiotherapy
|
The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)
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Six months after end of radiotherapy
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Loco-regional tumor control
Prazo: Up to five years after end of radiotherapy
|
Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure. Rates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint. |
Up to five years after end of radiotherapy
|
|
Overall survival
Prazo: Up to five years after end of radiotherapy]
|
From date of randomisation to date of death
|
Up to five years after end of radiotherapy]
|
|
Acute toxicity
Prazo: From the beginning of and up to two months after end of radiotherapy]
|
DAHANCA acute toxicity score (grade 0-4, 0 being best)
|
From the beginning of and up to two months after end of radiotherapy]
|
|
Late toxicity
Prazo: From two months to five years after end of radiotherapy]
|
DAHANCA late toxicity score (grade 0-4, 0 being best)
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From two months to five years after end of radiotherapy]
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|
EORTC QLQ-Head-Neck 35
Prazo: Up to five years after end of radiotherapy
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Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)
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Up to five years after end of radiotherapy
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|
EORTC C30
Prazo: Up to five years after end of radiotherapy]
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Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
|
Up to five years after end of radiotherapy]
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Time from referral to treatment
Prazo: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
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Time from referral to proton center to first proton treatment
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From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeppe Friborg, MD, PhD, Danish Head-Neck Cancer Group (DAHANCA)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
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
- DAHANCA proton feasibility
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