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O estudo clínico NCT06883604 (PRO-Hodgkin) para Linfoma de Hodgkin está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin 75

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06883604 (PRO-Hodgkin) é um estudo intervencionista para Linfoma de Hodgkin. Seu status atual é: em recrutamento. O estudo começou em 1 de setembro de 2019 e pretende incluir 75 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 1 de junho de 2041. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de março de 2025.
Resumo
Hodgkin Lymphoma patients with limited stage are commonly cured with limited chemotherapy followed by radiotherapy. Studies have shown a risk of late toxicity from the radiotherapy, such as second cancer, heart failure and lung toxicity. With proton therapy the dose to normal tissue can be minimised without compromising the dose to the tumor. The aim of our study is to investigate whether proton therapy can be delive...Mostrar mais
Título oficial

Clinical Investigation of PBS Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

Condições médicas
Linfoma de Hodgkin
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • PRO-Hodgkin
  • 2019-00010
Número NCT
NCT06883604
Data de início (real)
2019-09-01
Última atualização postada
2025-03-19
Data de conclusão (estimada)
2041-06
Inscrição (estimada)
75
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Proton therapy
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalProton therapy
Stage 1-2A Hodgkin Lymphoma.
Proton therapy.
Pencil beam scanning proton therapy to a dose of 20 or 29.75 Gy (RBE) after standard chemotherapy (2-4 ABVD).
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Progression free survival (PFS)
Time from study entry until disease progression or death from any cause.
Outcome will be measured after 1, 3, 5 and 16 years.
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Overall survival (OS)
Time from diagnostic biopsy until death from any cause.
Outcome will be measured after 1, 3, 5 and 16 years.
Time to progression (TTP)
Time from diagnostic biopsy until objective tumor progression, not includingdeath.
Outcome will be measured after 1, 3, 5 and 16 years.
Absorbed dose to organs at risk.
Will be collected from Dose Volume Histograms.
Outcome will be measured at baseline.
Patterns of failure.
Are failures located within or outside of the radiation field?
Outcome will be measured after 1, 3, 5 and 16 years.
Acute adverse events.
The incidence of acute toxicities during treatment will be summarized by severity (based on CTCAE grades), type and relation to the study therapy. Acute adverse events are defined as occurring during or within 3 months after radiotherapy.
Outcome will be measured within 3 months.
Long-term adverse events.
This study specifically includes longitudinal follow-up to assess the incidence of secondary malignant neoplasms, heart- and lung toxicity measured up to 16 years following radiotherapy. Late adverse events are defined as occurring 3 months or later.
Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
EORTC quality of life questionnaire (QLQ)-C30.
Outcome will be measured after 1, 3, 5 and 16 years.
Quality of life.
EORTC quality of life questionnaire (QLQ)-Hodgkin lymphoma (HL)27.
Outcome will be measured after 1, 3, 5 and 16 years.
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
  • Histological diagnosis of classic Hodgkin Lymphoma.
  • Ann Arbour stage 1A, 1B or 2A.
  • Both patients with and without risk factors, i.e. bulky disease, erythrocyte sedimentation rate (ESR)>50, more than two involved sites.
  • Supra diaphragmal disease.
  • Age 18-60 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  • Initial staging positron emission tomography/computed tomography (PET/CT).
  • Induction chemotherapy including 2 cycles of ABVD for patients without risk factors and 4 cycles of ABVD for patients with risk factors.
  • For patients with risk factors a CT after 2 ABVD confirming complete remission (CR) or partial remission (PR). For patients without risk factors clinical response is sufficient at inclusion, but a CT scan is recommended before start of radiotherapy.
  • Radiotherapy (RT) start not later than 6 weeks after end of chemotherapy.
  • Written informed consent obtained prior to any study specific procedures.
  • Women of reproductive age must agree to use contraceptives during the study treatment period.

  • Pregnancy.
  • Serious concomitant systemic disorder endangering treatment delivery.
  • More than 5mm tumour motion on 4 dimensional computed tomography (4DCT) unless deep inspiration breath hold (DIBH) is used. Not applicable if target is located outside mediastinum or photon treatment is planned.
  • Clinical or radiographic stable disease (SD)/ progressive disease (PD) during induction chemotherapy.
  • Not able to comply with treatment and study procedures.
  • No additional active malignancy except indolent lymphoma in the bone marrow, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.
Uppsala University Hospital logoUniversidade de Uppsala
Responsável pelo estudo
Daniel Molin, Investigador principal, MD, PhD, associate professor, Uppsala University Hospital
Contato central do estudo
Contato: Daniel Molin, MD, PhD, +46186110000, [email protected]
Contato: Christina Goldkuhl, MD, +46313421000, [email protected]
6 Locais do estudo em 1 países
Sahlgrenska University Hospital, Gothenburg, S-41345, Sweden
Christina Goldkuhl, MD, Contato
Em recrutamento
Skane University Hospital, Lund, S-22242, Sweden
Johan Linderoth, MD, Phd, Contato
Em recrutamento
Orebro University Hospital, Örebro, S-70185, Sweden
Jenny Kahlmeter Brandell, Contato
Em recrutamento
Karolinska University Hospital, Solna, S-17176, Sweden
Marzia Palma, MD, PhD, Contato
Lotta Hansson, Subinvestigador
Em recrutamento
Umea University Hospital, Umeå, S-90737, Sweden
Ann-Sofie Johansson, MD, PhD, Contato
Em recrutamento
Uppsala University Hospital, Uppsala, S-75185, Sweden
Daniel Molin, MD, PhD, Contato
Em recrutamento