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O estudo clínico NCT06568705 para Câncer de mama 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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Faculdade de Medicina da União de PequimHypofractionated Online Adaptive Radiotherapy of Breast Cancer Fase II 40 Design adaptativo
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O estudo clínico NCT06568705 procura avaliar tratamento para Câncer de mama. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 1 de setembro de 2024 e pretende incluir 40 participantes. Coordenado por Faculdade de Medicina da União de Pequim e deve ser concluído em 1 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de março de 2026.
Resumo
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:
- Can online adaptive radiotherapy improve the accuracy of dose delivery?
- In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities ...
Descrição detalhada
Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body positio...Mostrar mais
Título oficial
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
Condições médicas
Câncer de mamaOutros IDs do estudo
- HF_BCoART
Número NCT
Data de início (real)
2024-09-01
Última atualização postada
2026-03-20
Data de conclusão (estimada)
2026-12
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Palavras-chave
Online Adaptive Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
Propósito principal
Tratamento
Alocação do design
Não randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Experimental26Gy/5f online adaptive radiotherapy The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy. | Ultrafractionated Radiation Treatment The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy. |
Comparador ativo43.5Gy/15f online adaptive radiotherapy The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy. | Moderate hypofractionated Radiation Treatment The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
The dose coverage of target volume as assessed by planning tumor volume V100% | Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume. | 3 months after radiotherapy |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Treatment-related toxicity | Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0. | Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy. |
Local recurrence rate (LRR) | LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse. | 3, 6, 12, 24 months after radiotherapy |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
35 Years
Sexos elegíveis
Feminino
- Female, aged ≥35 years, <70 years
- ECOG score: 0-2
- Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
- Pathologically confirmed primary breast cancer
- For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
- Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
- Able to cooperate and tolerate the treatment
- Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
- History of radiotherapy to the neck or chest
- Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
- History of malignant tumors
Faculdade de Medicina da União de Pequim482 estudos clínicos ativos para explorarContato central do estudo
Contato: Xiaorong Hou, MD, +86-13811963013, [email protected]
Contato: Xiaorong Hou, +86-13811963013, [email protected]
1 Locais do estudo em 1 países
Peking Union Medical College Hospital, Beijing, China
Xiaorong Hou, MD, Contato, +86-13811963013, [email protected]
Em recrutamento