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Breast CancerPhase 3NCT00377156

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

A Phase 3 study testing radiation therapy and stereotactic radiosurgery in people with Breast Cancer and Cognitive/Functional Effects, run by Alliance for Clinical Trials in Oncology at 64 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
radiation therapy and stereotactic radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
64 sitesin 2 countries
Study dates
Jul 2006to 15 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

United States60 sites

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Cape Fear Valley Medical Center Cancer Center

    Fayetteville, North Carolina, 28302-2000

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Greenville Cancer Center of the Carolinas (CCOP)

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Memorial Medical Center

    Modesto, California, 95355

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Kaiser Permanente - Division of Research - Oakland

    Oakland, California, 94611

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Owensboro Mercy Medical Center

    Owensboro, Kentucky, 42303

  • Frankford Hospital Cancer Center - Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Arizona Oncology-Deer Valley Center

    Phoenix, Arizona, 85027

  • Legacy Good Samaritan Hospital & Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Somerset Medical Center

    Somerville, New Jersey, 08876

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Legacy Salmon Creek Medical Center

    Vancouver, Washington, 98686

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Coastal Carolina Radiation Oncology Center

    Wilmington, North Carolina, 28401

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Saint Vincent Hospital at Worcester Medical Center

    Worcester, Massachusetts, 01608

Other trials in United States

Canada4 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • CHUS-Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

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.

Being tested
radiation therapy, stereotactic radiosurgery
Keywords
cognitive/functional effects, tumors metastatic to brain, stage IV breast cancer, stage IV prostate cancer, stage IV non-small cell lung cancer, male breast cancer, recurrent breast cancer, recurrent prostate cancer, recurrent non-small cell lung cancer
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Prostatic Neoplasms, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapyRadiation

    Patients undergo radiation therapy 5 days a week for 2.5 weeks

  • stereotactic radiosurgeryRadiation

Study groups in NCT00377156
Study groupRoleWhat they receive
Arm IActive comparatorPatients undergo stereotactic radiosurgery (SRS)
Receives: Radiation: stereotactic radiosurgery
Arm IIExperimentalPatients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
Receives: Radiation: radiation therapy; Radiation: stereotactic radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months

    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.

    Measured: 3 months post radiosurgery

Secondary outcomes (4)

  1. Number of Participants With Local and Distant Tumor Control up to 3 Months

    Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....

    Measured: Up to 3 months

  2. Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]

    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.

    Measured: From Baseline to 3-Month Evaluation

  3. Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 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.

    Measured: From baseline to 12 months

  4. Overall Survival

    Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2014
  4. Study completion15 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377156
Sponsor's protocol ID
N0574
Other IDs
NCCTG-N0574, ACOSOG-N0574, CDR0000499633, NCI-2009-00653
Status last verified
Sep 2022
First submitted
13 Sep 2006
Last updated
16 Sep 2022
Data monitoring committee
Yes

Publications

  • Churilla TM, Ballman KV, Brown PD, Twohy EL, Jaeckle K, Farace E, Cerhan JH, Anderson SK, Carrero XW, Garces YI, Barker FG 2nd, Deming R, Dixon JG, Burri SH, Chung C, Menard C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Stereotactic Radiosurgery With or Without Whole-Brain Radiation Therapy for Limited Brain Metastases: A Secondary Analysis of the North Central Cancer Treatment Group N0574 (Alliance) Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2017 Dec 1;99(5):1173-1178. doi: 10.1016/j.ijrobp.2017.07.045. Epub 2017 Aug 5.

    PubMed 28939223

  • Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard 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):401-409. doi: 10.1001/jama.2016.9839.

    PubMed 27458945

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radiation therapy and stereotactic radiosurgery in people with Breast Cancer and Cognitive/Functional Effects, run by Alliance for Clinical Trials in Oncology at 64 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months (time frame: 3 months post radiosurgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377156, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

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