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Trial record 1 of 1 for:    n0574
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Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377156
First Posted: September 15, 2006
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
September 13, 2006
September 15, 2006
February 27, 2017
August 24, 2017
August 24, 2017
July 2006
October 2014   (Final data collection date for primary outcome measure)
Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months [ Time Frame: 3 months post radiosurgery ]
The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.
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Complete list of historical versions of study NCT00377156 on ClinicalTrials.gov Archive Site
  • Number of Participants With Local and Distant Tumor Control up to 3 Months [ Time Frame: Up to 3 months ]
    Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....
  • Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month] [ Time Frame: From Baseline to 3-Month Evaluation ]
    Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.
  • Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months [ Time Frame: From baseline to 12 months ]

    Long-Term Neurocognitive Status

    > To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.

  • Overall Survival [ Time Frame: Up to 5 years ]
    Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.
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Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.

PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.

OBJECTIVES:

Primary

  • Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy.

Secondary

  • Compare time to CNS (brain) failure in patients treated with these regimens.
  • Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens.
  • Compare post-treatment toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for > 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo stereotactic radiosurgery (SRS).
  • Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months.

PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Cognitive/Functional Effects
  • Lung Cancer
  • Metastatic Cancer
  • Prostate Cancer
  • Radiation: radiation therapy
    Patients undergo radiation therapy 5 days a week for 2.5 weeks
  • Radiation: stereotactic radiosurgery
  • Active Comparator: Arm I
    Patients undergo stereotactic radiosurgery (SRS)
    Intervention: Radiation: stereotactic radiosurgery
  • Experimental: Arm II
    Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
    Interventions:
    • Radiation: radiation therapy
    • Radiation: stereotactic radiosurgery
Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Ménard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-9. doi: 10.1001/jama.2016.9839.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
213
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October 2014   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of cerebral metastases meeting the following criteria:

    • One to three presumed brain metastases
    • Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)

      • Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s)
    • Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days
    • Lesions must not be within 5 mm of the optic chiasm or within the brainstem
  • Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist
  • No primary germ cell tumor, small cell carcinoma, or lymphoma
  • No leptomeningeal metastases
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • ECOG performance status 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 the body
  • No known allergy to gadolinium

PRIOR CONCURRENT THERAPY:

  • More than 7 days since prior and no concurrent chemotherapy
  • No prior cranial radiotherapy
  • No prior resection of cerebral metastases
  • Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00377156
N0574
NCCTG-N0574
ACOSOG-N0574
CDR0000499633 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00653 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Yes
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Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Paul D. Brown, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP