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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 februari 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

126

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv 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.
Strålning: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Andra namn:
  • 3-dimensionell strålbehandling
  • 3D KONFORMAL STRÅLTERAPI
  • 3D CRT
  • 3D-CRT
  • Konformal terapi
  • Strålningskonform terapi
Strålning: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Andra namn:
  • Stereotaktisk extern strålbestrålning
  • stereotaktisk extern strålbehandling
  • stereotaktisk strålbehandling
  • Stereotaktisk strålbehandling
  • stereotaxisk strålbehandling
  • stereotaxisk strålkirurgi
Experimentell: 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.
Läkemedel: Temozolomid
Ges oralt
Andra namn:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-karboxamid, 3,4-dihydro-3-metyl-4-oxo-
  • M & B 39831
  • M och B 39831
Strålning: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Andra namn:
  • 3-dimensionell strålbehandling
  • 3D KONFORMAL STRÅLTERAPI
  • 3D CRT
  • 3D-CRT
  • Konformal terapi
  • Strålningskonform terapi
Strålning: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Andra namn:
  • Stereotaktisk extern strålbestrålning
  • stereotaktisk extern strålbehandling
  • stereotaktisk strålbehandling
  • Stereotaktisk strålbehandling
  • stereotaxisk strålbehandling
  • stereotaxisk strålkirurgi
Experimentell: 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.
Läkemedel: Erlotinib hydroklorid
Ges oralt
Andra namn:
  • Cp-358,774
  • Tarceva
  • OSI-774
Strålning: 3-Dimensional Conformal Radiation Therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Andra namn:
  • 3-dimensionell strålbehandling
  • 3D KONFORMAL STRÅLTERAPI
  • 3D CRT
  • 3D-CRT
  • Konformal terapi
  • Strålningskonform terapi
Strålning: Stereotactic Radiosurgery
Patients undergo surgery after radiation therapy
Andra namn:
  • Stereotaktisk extern strålbestrålning
  • stereotaktisk extern strålbehandling
  • stereotaktisk strålbehandling
  • Stereotaktisk strålbehandling
  • stereotaxisk strålbehandling
  • stereotaxisk strålkirurgi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of CNS Progression (One Year)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Samarbetspartners

Radiation Therapy Oncology Group

Utredare

  • Huvudutredare: Paul Sperduto, Radiation Therapy Oncology Group

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 oktober 2004

Primärt slutförande (Faktisk)

14 juni 2011

Avslutad studie (Faktisk)

1 april 2012

Studieregistreringsdatum

Först inskickad

9 november 2004

Först inskickad som uppfyllde QC-kriterierna

8 november 2004

Första postat (Uppskatta)

9 november 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 mars 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2009-00720 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • U10CA021661 (U.S.S. NIH-anslag/kontrakt)
  • CDR0000389490
  • RTOG 0320 (Annan identifierare: Radiation Therapy Oncology Group)
  • RTOG-0320 (Annan identifierare: CTEP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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