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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 lutego 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

126

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Promieniowanie: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Inne nazwy:
  • Trójwymiarowa radioterapia
  • KONFORMALNA TERAPIA PROMIENIOWANIEM 3D
  • Kineskop 3D
  • 3D-CRT
  • Terapia konformalna
  • Konformalna terapia radiacyjna
Promieniowanie: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Inne nazwy:
  • Stereotaktyczne napromieniowanie wiązką zewnętrzną
  • stereotaktyczna radioterapia wiązkami zewnętrznymi
  • radioterapia stereotaktyczna
  • Radioterapia stereotaktyczna
  • radiochirurgia stereotaktyczna
Eksperymentalny: 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.
Lek: Temozolomid
Podany doustnie
Inne nazwy:
  • Temodara
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolaston
  • RP-46161
  • Temomedak
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazyno-8-karboksyamid, 3,4-dihydro-3-metylo-4-okso-
  • M&B 39831
  • M i B 39831
Promieniowanie: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Inne nazwy:
  • Trójwymiarowa radioterapia
  • KONFORMALNA TERAPIA PROMIENIOWANIEM 3D
  • Kineskop 3D
  • 3D-CRT
  • Terapia konformalna
  • Konformalna terapia radiacyjna
Promieniowanie: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Inne nazwy:
  • Stereotaktyczne napromieniowanie wiązką zewnętrzną
  • stereotaktyczna radioterapia wiązkami zewnętrznymi
  • radioterapia stereotaktyczna
  • Radioterapia stereotaktyczna
  • radiochirurgia stereotaktyczna
Eksperymentalny: 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.
Lek: Chlorowodorek erlotynibu
Podany doustnie
Inne nazwy:
  • Cp-358774
  • Tarcewa
  • OSI-774
Promieniowanie: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Inne nazwy:
  • Trójwymiarowa radioterapia
  • KONFORMALNA TERAPIA PROMIENIOWANIEM 3D
  • Kineskop 3D
  • 3D-CRT
  • Terapia konformalna
  • Konformalna terapia radiacyjna
Promieniowanie: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Inne nazwy:
  • Stereotaktyczne napromieniowanie wiązką zewnętrzną
  • stereotaktyczna radioterapia wiązkami zewnętrznymi
  • radioterapia stereotaktyczna
  • Radioterapia stereotaktyczna
  • radiochirurgia stereotaktyczna

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Rate of CNS Progression (One Year)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Cancer Institute (NCI)

Współpracownicy

Radiation Therapy Oncology Group

Śledczy

  • Główny śledczy: Paul Sperduto, Radiation Therapy Oncology Group

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 października 2004

Zakończenie podstawowe (Rzeczywisty)

14 czerwca 2011

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2012

Daty rejestracji na studia

Pierwszy przesłany

9 listopada 2004

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 listopada 2004

Pierwszy wysłany (Oszacować)

9 listopada 2004

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 marca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 lutego 2018

Ostatnia weryfikacja

1 lutego 2018

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NCI-2009-00720 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
  • U10CA021661 (Grant/umowa NIH USA)
  • CDR0000389490
  • RTOG 0320 (Inny identyfikator: Radiation Therapy Oncology Group)
  • RTOG-0320 (Inny identyfikator: CTEP)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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