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Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

9 de fevereiro de 2018 atualizado por: National Cancer Institute (NCI)

A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor. It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVES:

I. Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or erlotinib.

SECONDARY OBJECTIVES:

I. Compare time to CNS progression in patients treated with these regimens. II. Compare quality-adjusted survival in patients treated with these regimens. III. Compare 3-month quality of life in patients treated with these regimens. IV. Compare the 6-month performance status of patients treated with these regimens.

V. Compare 6-month steroid dependence in patients treated with these regimens. VI. Compare cause of death (neurologic vs other) in patients treated with these regimens.

VII. Determine the effects of non-protocol chemotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and the presence of extracranial metastases (< 65 years old AND no extracranial metastases vs ≥ 65 years old OR extracranial metastases), number of metastases (1 vs 2 or 3), and extent of extracranial disease (none vs present). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.

ARM II: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.

In all arms, patients with recurrent brain metastases may undergo additional stereotactic radiosurgery.

Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Tipo de estudo

Intervencional

Inscrição (Real)

126

Estágio

  • Fase 3

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

  • Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3E 0V9
        • CancerCare Manitoba
    • Ontario
      • Ottawa, Ontario, Canadá, K1Y 4E9
        • Ottawa Hospital-Civic Campus
    • Quebec
      • Montreal, Quebec, Canadá, H2W 1S6
        • McGill University Department of Oncology
  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85260
        • Arizona Oncology Services Foundation
      • Scottsdale, Arizona, Estados Unidos, 85260
        • Scottsdale Health Care-Osborn
    • California
      • Burbank, California, Estados Unidos, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Los Angeles, California, Estados Unidos, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Pomona, California, Estados Unidos, 91767
        • Pomona Valley Hospital Medical Center
    • Colorado
      • Grand Junction, Colorado, Estados Unidos, 81501
        • Saint Mary's Hospital and Regional Medical Center
    • Delaware
      • Newark, Delaware, Estados Unidos, 19718
        • Christiana Care Health System-Christiana Hospital
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, Estados Unidos, 32258
        • Baptist Medical Center South
      • Jacksonville, Florida, Estados Unidos, 32207
        • Integrated Community Oncology Network-Southside Cancer Center
      • Jacksonville Beach, Florida, Estados Unidos, 32250
        • Integrated Community Oncology Network-Florida Cancer Center Beaches
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orange Park, Florida, Estados Unidos, 32073
        • 21st Century Oncology-Orange Park
      • Orlando, Florida, Estados Unidos, 32806
        • UF Cancer Center at Orlando Health
      • Palatka, Florida, Estados Unidos, 32177
        • 21st Century Oncology-Palatka
      • Panama City, Florida, Estados Unidos, 32401
        • Bay Medical Center
      • Saint Augustine, Florida, Estados Unidos, 32086
        • Integrated Community Oncology Network-Flager Cancer Center
      • Tallahassee, Florida, Estados Unidos, 32308
        • Tallahassee Memorial HealthCare
    • Georgia
      • Columbus, Georgia, Estados Unidos, 31904
        • John B Amos Cancer Center
    • Idaho
      • Boise, Idaho, Estados Unidos, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Arlington Heights, Illinois, Estados Unidos, 60005
        • Northwest Community Hospital
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • Harvey, Illinois, Estados Unidos, 60426
        • Ingalls Memorial Hospital
      • Springfield, Illinois, Estados Unidos, 62702
        • Saint John's Hospital
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46805
        • Parkview Hospital Randallia
      • Hammond, Indiana, Estados Unidos, 46320
        • Franciscan Saint Margaret Health-Hammond Campus
      • Indianapolis, Indiana, Estados Unidos, 46202
        • IU Health Methodist Hospital
    • Iowa
      • Dubuque, Iowa, Estados Unidos, 52001
        • Finley Hospital
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40207
        • Norton Suburban Hospital and Medical Campus
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, Estados Unidos, 21229
        • Saint Agnes Hospital
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University Of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Estados Unidos, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • West Michigan Cancer Center
    • Minnesota
      • Burnsville, Minnesota, Estados Unidos, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Estados Unidos, 55433
        • Mercy Hospital
      • Edina, Minnesota, Estados Unidos, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Estados Unidos, 55432
        • Unity Hospital
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota/Masonic Cancer Center
      • Robbinsdale, Minnesota, Estados Unidos, 55422
        • North Memorial Medical Health Center
      • Saint Cloud, Minnesota, Estados Unidos, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, Estados Unidos, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • United Hospital
      • Waconia, Minnesota, Estados Unidos, 55387
        • Ridgeview Medical Center
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Saint Louis University Hospital
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • Nevada Cancer Research Foundation CCOP
      • Reno, Nevada, Estados Unidos, 89502
        • Renown Regional Medical Center
    • New Jersey
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Red Bank, New Jersey, Estados Unidos, 07701
        • Riverview Medical Center/Booker Cancer Center
      • Sparta, New Jersey, Estados Unidos, 07871
        • Sparta Cancer Treatment Center
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Mission Hospital-Memorial Campus
    • Ohio
      • Akron, Ohio, Estados Unidos, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Pennsylvania
      • Drexel Hill, Pennsylvania, Estados Unidos, 19026
        • Delaware County Memorial Hospital
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Estados Unidos, 19103
        • Radiation Therapy Oncology Group
      • West Reading, Pennsylvania, Estados Unidos, 19611
        • Reading Hospital
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37916
        • Thompson Cancer Survival Center
    • Texas
      • Arlington, Texas, Estados Unidos, 76012
        • Arlington Cancer Center
      • Dallas, Texas, Estados Unidos, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Galveston, Texas, Estados Unidos, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, Estados Unidos, 77030
        • M D Anderson Cancer Center
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Intermountain Medical Center
      • Ogden, Utah, Estados Unidos, 84403
        • McKay-Dee Hospital Center
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Estados Unidos, 84143
        • LDS Hospital
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, Estados Unidos, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Washington
      • Seattle, Washington, Estados Unidos, 98101
        • Virginia Mason Medical Center
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
        • University of Wisconsin Hospital and Clinics
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Froedtert and The Medical College of Wisconsin
      • Racine, Wisconsin, Estados Unidos, 53405
        • Wheaton Franciscan Cancer Care - All Saints

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer

  • One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:

    • Well circumscribed tumor(s)

    • Maximum diameter ≤ 4.0 cm

      • If multiple lesions are present and one lesion is at the maximum diameter, the other lesions must not exceed 3.0 cm in maximum diameter
    • No metastases within 10 mm of the optic apparatus such that a portion of the optic nerve or chiasm would be included in the high-dose stereotactic radiosurgery boost field
    • No metastases in the brainstem, midbrain, pons, or medulla

  • No prior complete resection of all known brain metastases

    • Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter

  • No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month

    • Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease

  • Stable extracranial metastases allowed

    • No known or pre-existing liver metastases
  • No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
  • Synchronous brain metastases at initial diagnosis allowed
  • Performance status - Zubrod 0-1
  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST < 2 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases
  • Total bilirubin normal
  • Lactic dehydrogenase < 2 times ULN
  • Creatinine < 1.5 times ULN

  • No clinically active interstitial lung disease

    • Chronic stable asymptomatic radiographic changes allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Neurologic function status 0-2
  • No other major medical illness or psychiatric impairment that would preclude study participation
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to erlotinib or temozolomide
  • No concurrent immunotherapy
  • No concurrent biologic therapy, excluding growth factors and epoetin alfa
  • No prior temozolomide or erlotinib

  • No other concurrent chemotherapy during study radiotherapy

    • Other concurrent chemotherapy allowed after study radiotherapy, except for the following:

      • Temozolomide or erlotinib (arm I only)
      • Erlotinib (arm II only)
      • Temozolomide (arm III only)
  • No prior cranial radiotherapy
  • No concurrent intensity-modulated radiotherapy

  • Concurrent radiotherapy to painful bone lesions allowed

    • No concurrent radiotherapy to more than 15% of bone marrow
  • No other concurrent therapy for brain metastases unless a recurrence is detected
  • More than 30 days since prior investigational drugs

  • No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following (for patients randomized to receive erlotinib):

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Phenobarbital
    • Primidone
    • Oxcarbazepine
  • No other concurrent investigational drugs
  • No concurrent Hypericum perforatum (St. John's wort)
  • No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within 4 hours after erlotinib administration (arm III patients only)

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm I
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Radiação: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Outros nomes:
  • Radioterapia tridimensional
  • TERAPIA DE RADIAÇÃO CONFORMAL 3D
  • CRT 3D
  • 3D-CRT
  • Terapia Conformal
  • Radioterapia Conformal
Radiação: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Outros nomes:
  • Irradiação Estereotáxica de Feixe Externo
  • radioterapia estereotáxica de feixe externo
  • radioterapia estereotáxica
  • Radioterapia Estereotáxica
  • radiocirurgia estereotáxica
Experimental: Arm II
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Medicamento: Temozolomida
Dado oralmente
Outros nomes:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastona
  • RP-46161
  • Temomedac
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazina-8-carboxamida, 3,4-dihidro-3-metil-4-oxo-
  • M&B 39831
  • M e B 39831
Radiação: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Outros nomes:
  • Radioterapia tridimensional
  • TERAPIA DE RADIAÇÃO CONFORMAL 3D
  • CRT 3D
  • 3D-CRT
  • Terapia Conformal
  • Radioterapia Conformal
Radiação: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Outros nomes:
  • Irradiação Estereotáxica de Feixe Externo
  • radioterapia estereotáxica de feixe externo
  • radioterapia estereotáxica
  • Radioterapia Estereotáxica
  • radiocirurgia estereotáxica
Experimental: Arm III
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Medicamento: Cloridrato De Erlotinibe
Dado oralmente
Outros nomes:
  • Cp-358.774
  • Tarceva
  • OSI-774
Radiação: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Outros nomes:
  • Radioterapia tridimensional
  • TERAPIA DE RADIAÇÃO CONFORMAL 3D
  • CRT 3D
  • 3D-CRT
  • Terapia Conformal
  • Radioterapia Conformal
Radiação: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Outros nomes:
  • Irradiação Estereotáxica de Feixe Externo
  • radioterapia estereotáxica de feixe externo
  • radioterapia estereotáxica
  • Radioterapia Estereotáxica
  • radiocirurgia estereotáxica

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Survival
Prazo: From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.
From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of CNS Progression (One Year)
Prazo: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.
From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument
Prazo: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).
From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months
Prazo: From randomization to three months.
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.
From randomization to three months.
Change in Performance Status at Six Months
Prazo: From randomization to six months.
Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.
From randomization to six months.
Change in Steroid Dependence at Six Months
Prazo: From randomization to six months.
Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.
From randomization to six months.
Cause of Death (Neurologic vs Other)
Prazo: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
Patients were considered to have died neurologic deaths (coded as "Brain Metastases") if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis.
From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Colaboradores

Radiation Therapy Oncology Group

Investigadores

  • Investigador principal: Paul Sperduto, Radiation Therapy Oncology Group

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 (Real)

6 de outubro de 2004

Conclusão Primária (Real)

14 de junho de 2011

Conclusão do estudo (Real)

1 de abril de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

9 de novembro de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de novembro de 2004

Primeira postagem (Estimativa)

9 de novembro de 2004

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de março de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de fevereiro de 2018

Última verificação

1 de fevereiro de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2009-00720 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • U10CA021661 (Concessão/Contrato do NIH dos EUA)
  • CDR0000389490
  • RTOG 0320 (Outro identificador: Radiation Therapy Oncology Group)
  • RTOG-0320 (Outro identificador: CTEP)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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