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Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

6. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
  • Compare the time to CNS failure (brain) in patients treated with these regimens.
  • Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
  • Compare the post-treatment toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiosurgery.
  • Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.

Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

480

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3295
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Foundation for Cancer Research and Education
      • Phoenix, Arizona, Forenede Stater, 85001-2071
        • St. Joseph's Hospital and Medical Center
    • California
      • Concord, California, Forenede Stater, 94524-4110
        • Mount Diablo Regional Cancer Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Cancer center
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Comprehensive Cancer Center
      • Walnut Creek, California, Forenede Stater, 94598
        • John Muir Comprehensive Cancer Center at John Muir Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520-8040
        • Yale Comprehensive Cancer Center
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-100277
        • Shands Cancer Center at the University of Florida Health Science Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois Medical Center
    • Iowa
      • Davenport, Iowa, Forenede Stater, 52803
        • Genesis Regional Cancer Center at Genesis Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • New Jersey
      • Edison, New Jersey, Forenede Stater, 08818
        • John F. Kennedy Medical Center
    • New York
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Carolina Neurosurgery and Spine Associates
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Durham, North Carolina, Forenede Stater, 27705
        • American College of Surgeons Oncology Group
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212-4772
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15215
        • UPMC St. Margaret
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-2582
        • University of Pittsburgh Medical Center - Shadyside Hospital
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38104
        • Methodist Cancer Center at Methodist University Hospital
    • Utah
      • American Fork, Utah, Forenede Stater, 84003
        • American Fork Hospital
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Cancer Center at the University of Virginia
      • Richmond, Virginia, Forenede Stater, 23298-0631
        • Massey Cancer Center at Virginia Commonwealth University
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792-7375
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of cerebral metastases meeting all of the following requirements:

    • 1-3 de novo lesions
    • Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)
    • Each lesion must be less than 3.0 cm by contrasted MRI of the brain
    • Lesions must not be within 5 mm of optic chiasm or within the brainstem
  • No primary germ cell tumor, small cell carcinoma, or lymphoma
  • No leptomeningeal metastases
  • Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
  • Performance status - ECOG 0-2
  • Performance status - Zubrod 0-2
  • Not pregnant
  • Negative pregnancy test

  • Fertile patients must use effective contraception

    * Male patients must continue to use contraception for 3 months after the completion of radiotherapy

  • No pacemaker or other MRI-incompatible metal in body
  • No known allergy to gadolinium
  • Deemed to be at low risk for recurrence from any prior malignancies
  • At least 7 days since prior chemotherapy
  • Concurrent hormonal agents allowed
  • Concurrent steroids allowed
  • No prior cranial radiotherapy
  • No prior resection of cerebral metastasis
  • Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: radiosurgery

Patients undergo radiosurgery.

Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Procedure: kirurgi
Stråling: strålebehandling
Eksperimentel: radiosurgery + WBRT

Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.

Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Procedure: kirurgi
Stråling: strålebehandling
Stråling: WBRT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Overall survival (OS)
Tidsramme: Up to 6 months
Up to 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Time to CNS failure
Tidsramme: Up to 4 years
Up to 4 years
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Tidsramme: From baseline to up to 3 months
From baseline to up to 3 months
Change in the duration of functional independence using the Barthel ADL Index score
Tidsramme: From baseline to up to 4 years
From baseline to up to 4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2001

Primær færdiggørelse (Faktiske)

1. marts 2005

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

14. februar 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACOSOG-Z0300
  • CDR0000069183 (Anden identifikator: NCI Physician Data Query)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metastatisk kræft

Kliniske forsøg med kirurgi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner