Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
Visão geral do estudo
Status
Condições
Descrição detalhada
OBJECTIVES:
- To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
- To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.
OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.
Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 4 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston University Cancer Research Center
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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:
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage I or II disease (T1-3, N0, M0)
- T2 or T3 tumor ≤ 5 cm
- No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
- Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Exclusion Criteria:
- No history of contrast allergy
- No psychological issues that would preclude the completion of study treatment
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
- No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 56 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 62 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 68 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 56 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 62 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 68 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Prazo: 6 weeks
|
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
Prazo: 6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
Prazo: 6 weeks
|
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
Prazo: 6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Prazo: before treatment and at 1, 3, 6, and 12 months after treatment
|
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
|
before treatment and at 1, 3, 6, and 12 months after treatment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Minh Tam Truong, MD, Boston Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Mecanismos Moleculares de Ação Farmacológica
- Radiofármacos
- Fluorodesoxiglicose F18
Outros números de identificação do estudo
- H-26701
- CDR0000635119 (Número de outro subsídio/financiamento: Department of Defense)
Plano para dados de participantes individuais (IPD)
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