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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. Februar 2018 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

126

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Patients undergo radiation therapy once daily for approximately 3 weeks
Andere Namen:
  • 3-dimensionale Strahlentherapie
  • KONFORME 3D-STRAHLUNGSTHERAPIE
  • 3D-CRT
  • Konforme Therapie
  • Konforme Strahlentherapie
Patients undergo surgery after radiation therapy
Andere Namen:
  • Stereotaktische externe Strahlbestrahlung
  • stereotaktische Strahlentherapie mit externem Strahl
  • Stereotaktische Strahlentherapie
  • stereotaktische Strahlentherapie
  • stereotaktische Radiochirurgie
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.
Mündlich gegeben
Andere Namen:
  • Temodar
  • SCH52365
  • Temodal
  • Temcad
  • Methazolastein
  • RP-46161
  • Temomedac
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-carboxamid, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M und B 39831
Patients undergo radiation therapy once daily for approximately 3 weeks
Andere Namen:
  • 3-dimensionale Strahlentherapie
  • KONFORME 3D-STRAHLUNGSTHERAPIE
  • 3D-CRT
  • Konforme Therapie
  • Konforme Strahlentherapie
Patients undergo surgery after radiation therapy
Andere Namen:
  • Stereotaktische externe Strahlbestrahlung
  • stereotaktische Strahlentherapie mit externem Strahl
  • Stereotaktische Strahlentherapie
  • stereotaktische Strahlentherapie
  • stereotaktische Radiochirurgie
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.
Mündlich gegeben
Andere Namen:
  • Cp-358.774
  • Tarceva
  • OSI-774
Patients undergo radiation therapy once daily for approximately 3 weeks
Andere Namen:
  • 3-dimensionale Strahlentherapie
  • KONFORME 3D-STRAHLUNGSTHERAPIE
  • 3D-CRT
  • Konforme Therapie
  • Konforme Strahlentherapie
Patients undergo surgery after radiation therapy
Andere Namen:
  • Stereotaktische externe Strahlbestrahlung
  • stereotaktische Strahlentherapie mit externem Strahl
  • Stereotaktische Strahlentherapie
  • stereotaktische Strahlentherapie
  • stereotaktische Radiochirurgie

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of CNS Progression (One Year)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Paul Sperduto, Radiation Therapy Oncology Group

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Oktober 2004

Primärer Abschluss (Tatsächlich)

14. Juni 2011

Studienabschluss (Tatsächlich)

1. April 2012

Studienanmeldedaten

Zuerst eingereicht

9. November 2004

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. November 2004

Zuerst gepostet (Schätzen)

9. November 2004

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. März 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Februar 2018

Zuletzt verifiziert

1. Februar 2018

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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