A Registry Study of Permanent Breast Seed Implant
22 de outubro de 2021 atualizado por: Dr. Eric Leung, Sunnybrook Health Sciences Centre
A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.
The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.
Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.
Tipo de estudo
Intervencional
Inscrição (Real)
420
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M4N3M5
- Sunnybrook Odette Cancer Centre
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- A confirmed histological diagnosis of invasive breast carcinoma
- Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
- Surgical margins clear over or equal to 2 mm
- A maximum tumor size of 3 cm
- Age >= 50 years old
- ECOG performance status of 0 or 1
- Informed consent signed
Exclusion Criteria:
- Previous history of cancer other than curable skin SCC or Tis or T1 cervix
- Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
- Autoimmune disorder
- Diabetes insulin-dependant
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Post-operative breast infection
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node positive on axillary dissection or in the sentinel lymph node biopsy
- Extensive in situ carcinoma
- Multicentric disease (in more than one quadrant or separated by 2 cm or more)
- Paget's disease of the nipple
- Metastases
- Patients presenting a post-surgical fluid cavity ≥ 2.5 cm in diameter in any dimension as determined on the planning US
- Clear delineation of the target volume on CT is not possible
- Having a volume to be implanted over 120cc
- Having a target volume too close to skin such that the 85% isodose overlaps the skin surface)
- Having a target volume too close to the chest wall, such that there is a risk of perforating the chest wall
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
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 |
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Experimental: PBSI
PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.
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Patients are pre-planned using CT simulation.
Implant is realised under light sedation and local freezing.
Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle.
Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Serious Adverse Events
Prazo: Initial and then yearly up to 5 years
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Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death.
SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
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Initial and then yearly up to 5 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Breast cancer local recurrence
Prazo: Yearly up to 10 years
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Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.
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Yearly up to 10 years
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Regional recurrence
Prazo: Yearly up to 10 years
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Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection.
The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration.
Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).
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Yearly up to 10 years
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Metastases
Prazo: Yearly up to 10 years
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Distant recurrence is defined as evidence of tumor in any area of the body.
The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration
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Yearly up to 10 years
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PBSI side effects
Prazo: After procedure
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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After procedure
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PBSI side effects
Prazo: At 2 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 2 months
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PBSI side effect
Prazo: At 6 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 6 months
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PBSI side effect
Prazo: Yearly up to 10 years
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).
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Yearly up to 10 years
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Cosmetic outcome
Prazo: Yearly up to 10 years
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Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist.
An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects).
A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast.
A fair score means significant radiation effects were readily observable.
A poor score is used for severe sequelae of breast tissue secondary to radiation effects.
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Yearly up to 10 years
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Survival
Prazo: Yearly up to 10 years
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Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.
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Yearly up to 10 years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Eric Leung, MD, Sunnybrook Health Sciences Centre
Publicações e links úteis
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Publicações Gerais
- Pignol JP, Keller B, Rakovitch E, Sankreacha R, Easton H, Que W. First report of a permanent breast 103Pd seed implant as adjuvant radiation treatment for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):176-81. doi: 10.1016/j.ijrobp.2005.06.031. Epub 2005 Sep 22.
- Keller BM, Pignol JP, Rakovitch E, Sankreacha R, O'Brien P. A radiation badge survey for family members living with patients treated with a (103)Pd permanent breast seed implant. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):267-71. doi: 10.1016/j.ijrobp.2007.08.006. Epub 2007 Oct 29.
- Keller B, Sankreacha R, Rakovitch E, O'brien P, Pignol JP. A permanent breast seed implant as partial breast radiation therapy for early-stage patients: a comparison of palladium-103 and iodine-125 isotopes based on radiation safety considerations. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):358-65. doi: 10.1016/j.ijrobp.2004.10.014.
- Pignol JP, Rakovitch E, Keller BM, Sankreacha R, Chartier C. Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1482-8. doi: 10.1016/j.ijrobp.2008.06.1945. Epub 2008 Oct 18.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2009
Conclusão Primária (Real)
19 de janeiro de 2018
Conclusão do estudo (Real)
19 de janeiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
9 de abril de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de abril de 2010
Primeira postagem (Estimativa)
20 de abril de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de outubro de 2021
Última verificação
1 de outubro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PBSI Registry
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