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Trial record 1 of 1 for:    a071801
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Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114981
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm in the Brain Radiation: Single Fraction Stereotactic Radiosurgery Radiation: Fractionated Stereotactic Radiosurgery Procedure: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Diseases

Arm Intervention/treatment
Active Comparator: Arm I (SSRS)
Patients undergo SSRS over 1 session.
Radiation: Single Fraction Stereotactic Radiosurgery
Undergo SSRS
Other Name: Stereotactic Radiosurgery

Procedure: Quality-of-Life Assessment
Ancillary studies

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (FSRS)
Patients undergo FSRS over 3 or 5 daily sessions.
Radiation: Fractionated Stereotactic Radiosurgery
Undergo FSRS
Other Name: Stereotactic Radiosurgery

Procedure: Quality-of-Life Assessment
Ancillary studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Surgical bed recurrence-free survival (SB-RFS) [ Time Frame: From the time of randomization up to 2 years post radiation ]
    Surgical bed control is defined as the absence of new nodular contrast enhancement in the surgical bed. In other words, a surgical bed recurrence-free survival (SB-RFS) event is defined as radiographic evidence of a new contrast-enhancing lesion (specifically any new progressive enhancing nodularity) at the site of the surgical resection. Will use a stratified log-rank test that compares and will report the median SB-RFS times between the single fraction stereotactic radiosurgery (SSRS) and fractionated stereotactic radiosurgery (FSRS) arms while adjusting for the stratification factors.


Secondary Outcome Measures :
  1. Change in Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score [ Time Frame: At 9 months ]
    The average change from baseline to 9 months in the Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale will be compared between randomization arms.

  2. Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score [ Time Frame: At 9 months ]
    The average change from baseline to 9 months in the Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score will be compared between randomization arms.

  3. Linear Analog Self-Assessment (LASA) overall quality of life [ Time Frame: At 9 months ]
    The average change from baseline to 9 months in the Linear Analog Self-Assessment (LASA) overall total score will be compared between randomization arms.

  4. Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score for long-term survivors [ Time Frame: At 12 months ]
    Long-term survivors defined as patients who are alive more than 12 months from time of randomization. The average change from baseline to 12 months in the Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale for the long-term survivors will be compared between randomization arms.

  5. Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score for long-term survivors [ Time Frame: At 12 months ]
    Long-term survivors defined as patients who are alive more than 12 months from time of randomization. The average change from baseline to 12 months in the Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score for the long-term survivors will be compared between randomization arms.

  6. Linear Analog Self-Assessment (LASA) overall quality of life for long-term survivors [ Time Frame: At 12 months ]
    Long-term survivors defined as patients who are alive more than 12 months from time of randomization. The average change from baseline to 9 months in the Linear Analog Self-Assessment (LASA) overall total score for the long-term survivors will be compared between randomization arms.

  7. Karnofsky Performance Status (KPS) [ Time Frame: Up to 24 months ]
    The duration of Karnofsky Performance Status (KPS) functional independence will be the time to when the KPS scores per patient decrease below their baseline level and will be compared between treatment arms by the logrank test. Median durations of KPS functional independence will be reported and compared between randomization arms.

  8. Barthel Activities of Daily Living (ADL) Index [ Time Frame: Up to 24 months ]
    The duration of Barthel Activities of Daily Living (ADL) functional independence will be the time to when the ADL scores per patient decrease below their baseline level and will be compared between treatment arms by the logrank test. Median durations of ADL functional independence will be reported and compared between randomization arms.

  9. Karnofsky Performance Status (KPS) for long-term survivors [ Time Frame: Up to 24 months ]
    Long-term survivors defined as patients who are alive more than 12 months from time of randomization. The duration of Karnofsky Performance Status (KPS) functional independence will be the time to when the KPS scores per patient decrease below their baseline level and will be compared between treatment arms by the logrank test. Median durations of KPS functional independence for long-term survivors will be reported and compared between randomization arms.

  10. Barthel Activities of Daily Living (ADL) Index for long-term survivors [ Time Frame: Up to 24 months ]
    Long-term survivors defined as patients who are alive more than 12 months from time of randomization. The duration of Barthel Activities of Daily Living (ADL) functional independence will be the time to when the ADL scores per patient decrease below their baseline level and will be compared between treatment arms by the logrank test. Median durations of ADL functional independence for long-term survivors will be reported and compared between randomization arms.

  11. Overall survival [ Time Frame: Up to 5 years ]
    Overall survival time will be compared between the treatment arms using a stratified log-rank test. If the proportional hazards assumption is violated, a restricted means analysis will be used to compare overall survival between the two treatment arms. Median survival times per treatment arms will be reported.

  12. Incidence of adverse events [ Time Frame: Up to 24 months ]
    The Common Terminology Criteria for Adverse Events version 5.0 will be used. The proportion of patients experiencing any adverse event will be compared between the two treatment arms using a chi-square (or Fisher's exact test, if more appropriate).

  13. Proportion of patients with radiation necrosis [ Time Frame: At 24 months ]
    The proportion of patients with radiation necrosis within 24 months from of starting treatment will be compared between the treatment arms with a chi-square test (or Fisher's exact test if more appropriate).

  14. Time until whole-brain radiotherapy (WBRT) due to any reason (e.g. surgical bed recurrence, recurrence/progression at another central nervous system [CNS] site) [ Time Frame: Up to 24 months ]
    Time until whole-brain radiotherapy (WBRT) will be compared between the treatment arms using a stratified log-rank test. Median time until WBRT per treatment arms will be reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

PRE-REGISTRATION:

  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
  • Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening.

    o Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.

  • Unresected lesions must measure < 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept.

    o Note: The metastases size restriction does not apply to the resected brain metastasis.

  • One brain metastasis must be completely (gross total resection) resected =< 30 days prior to pre-registration.

    o NOTE: May not have had resection of more than one brain metastasis.

  • The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.
  • Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained =< 30 days prior to pre-registration.
  • Karnofsky performance status of >= 60.
  • For women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required.

    • Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
    • A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Ability to complete an MRI of the head with contrast.
  • The brain metastasis must be located > 5 mm of the optic chiasm and outside the brain stem.
  • Must not have any prior whole brain radiation therapy.
  • Past radiosurgery to other lesions is allowed.

    o NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol).

  • May not have primary germ cell tumor, small cell carcinoma, or lymphoma.
  • No evidence of leptomeningeal metastasis (LMD).

    o NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.

  • Must be fluent in English, Spanish, or French.

REGISTRATION:

• Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114981


Contacts
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Contact: Paul D. Brown, MD 507-284-3551 brown.paul@mayo.edu

Locations
Hide Hide 107 study locations
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United States, Arkansas
Mercy Hospital Fort Smith Suspended
Fort Smith, Arkansas, United States, 72903
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Suspended
Boise, Idaho, United States, 83706
Saint Alphonsus Cancer Care Center-Caldwell Suspended
Caldwell, Idaho, United States, 83605
Kootenai Medical Center Suspended
Coeur d'Alene, Idaho, United States, 83814
Walter Knox Memorial Hospital Suspended
Emmett, Idaho, United States, 83617
Idaho Urologic Institute-Meridian Suspended
Meridian, Idaho, United States, 83642
Saint Alphonsus Medical Center-Nampa Suspended
Nampa, Idaho, United States, 83686
Kootenai Cancer Center Suspended
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic Suspended
Sandpoint, Idaho, United States, 83864
United States, Illinois
Illinois CancerCare-Bloomington Suspended
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton Suspended
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale Suspended
Carbondale, Illinois, United States, 62902
SIH Cancer Institute Suspended
Carterville, Illinois, United States, 62918
Illinois CancerCare-Carthage Suspended
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic Suspended
Centralia, Illinois, United States, 62801
Cancer Care Specialists of Illinois - Decatur Suspended
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Dixon Suspended
Dixon, Illinois, United States, 61021
Crossroads Cancer Center Suspended
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka Suspended
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg Suspended
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center Suspended
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Kewanee Clinic Suspended
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb Suspended
Macomb, Illinois, United States, 61455
Good Samaritan Regional Health Center Suspended
Mount Vernon, Illinois, United States, 62864
Illinois CancerCare-Ottawa Clinic Suspended
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin Suspended
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Suspended
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria Suspended
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Suspended
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois Suspended
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center Suspended
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru Suspended
Peru, Illinois, United States, 61354
Valley Radiation Oncology Suspended
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton Suspended
Princeton, Illinois, United States, 61356
Southern Illinois University School of Medicine Suspended
Springfield, Illinois, United States, 62702
Springfield Clinic Suspended
Springfield, Illinois, United States, 62702
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois-Swansea Suspended
Swansea, Illinois, United States, 62226
Southwest Illinois Health Services LLP Suspended
Swansea, Illinois, United States, 62226
United States, Iowa
Mary Greeley Medical Center Suspended
Ames, Iowa, United States, 50010
McFarland Clinic PC - Ames Suspended
Ames, Iowa, United States, 50010
McFarland Clinic PC-Boone Suspended
Boone, Iowa, United States, 50036
McFarland Clinic PC-Trinity Cancer Center Suspended
Fort Dodge, Iowa, United States, 50501
McFarland Clinic PC-Jefferson Suspended
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown Suspended
Marshalltown, Iowa, United States, 50158
United States, Minnesota
Fairview Ridges Hospital Suspended
Burnsville, Minnesota, United States, 55337
Cambridge Medical Center Suspended
Cambridge, Minnesota, United States, 55008
Mercy Hospital Suspended
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital Suspended
Edina, Minnesota, United States, 55435
Unity Hospital Suspended
Fridley, Minnesota, United States, 55432
Fairview Maple Grove Medical Center Suspended
Maple Grove, Minnesota, United States, 55369
Minnesota Oncology Hematology PA-Maplewood Suspended
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast Suspended
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital Suspended
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center Suspended
Minneapolis, Minnesota, United States, 55415
Health Partners Inc Suspended
Minneapolis, Minnesota, United States, 55454
Monticello Cancer Center Suspended
Monticello, Minnesota, United States, 55362
New Ulm Medical Center Suspended
New Ulm, Minnesota, United States, 56073
Fairview Northland Medical Center Suspended
Princeton, Minnesota, United States, 55371
North Memorial Medical Health Center Suspended
Robbinsdale, Minnesota, United States, 55422
Coborn Cancer Center at Saint Cloud Hospital Suspended
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Clinic - Saint Louis Park Suspended
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Suspended
Saint Paul, Minnesota, United States, 55101
United Hospital Suspended
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center Suspended
Shakopee, Minnesota, United States, 55379
Lakeview Hospital Suspended
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center Suspended
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital Suspended
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury Suspended
Woodbury, Minnesota, United States, 55125
Fairview Lakes Medical Center Suspended
Wyoming, Minnesota, United States, 55092
United States, Missouri
Saint Louis Cancer and Breast Institute-Ballwin Suspended
Ballwin, Missouri, United States, 63011
Parkland Health Center-Bonne Terre Suspended
Bonne Terre, Missouri, United States, 63628
Cox Cancer Center Branson Suspended
Branson, Missouri, United States, 65616
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Southeast Cancer Center Suspended
Cape Girardeau, Missouri, United States, 63703
Parkland Health Center - Farmington Suspended
Farmington, Missouri, United States, 63640
Capital Region Southwest Campus Suspended
Jefferson City, Missouri, United States, 65109
Freeman Health System Suspended
Joplin, Missouri, United States, 64804
Mercy Hospital Joplin Suspended
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC Suspended
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology Suspended
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center Suspended
Saint Joseph, Missouri, United States, 64507
Saint Louis Cancer and Breast Institute-South City Suspended
Saint Louis, Missouri, United States, 63109
Mercy Hospital South Suspended
Saint Louis, Missouri, United States, 63128
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Mercy Hospital Saint Louis Suspended
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital Suspended
Sainte Genevieve, Missouri, United States, 63670
Mercy Hospital Springfield Suspended
Springfield, Missouri, United States, 65804
CoxHealth South Hospital Suspended
Springfield, Missouri, United States, 65807
Missouri Baptist Sullivan Hospital Suspended
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills Suspended
Sunset Hills, Missouri, United States, 63127
Mercy Hospital Washington Suspended
Washington, Missouri, United States, 63090
United States, Montana
Community Hospital of Anaconda Suspended
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center Suspended
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital Suspended
Bozeman, Montana, United States, 59715
Benefis Healthcare- Sletten Cancer Institute Suspended
Great Falls, Montana, United States, 59405
Great Falls Clinic Suspended
Great Falls, Montana, United States, 59405
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: John M. Schallenkamp         
Community Medical Hospital Suspended
Missoula, Montana, United States, 59804
United States, Oklahoma
Mercy Hospital Oklahoma City Suspended
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Saint Alphonsus Medical Center-Baker City Suspended
Baker City, Oregon, United States, 97814
Saint Alphonsus Medical Center-Ontario Suspended
Ontario, Oregon, United States, 97914
United States, Wisconsin
Gundersen Lutheran Medical Center Suspended
La Crosse, Wisconsin, United States, 54601
Cancer Center of Western Wisconsin Suspended
New Richmond, Wisconsin, United States, 54017
United States, Wyoming
Billings Clinic-Cody Suspended
Cody, Wyoming, United States, 82414
Welch Cancer Center Suspended
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Paul D. Brown, MD Mayo Clinic

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT04114981    
Other Study ID Numbers: A071801
NCI-2019-02394 ( Registry Identifier: NCI Clinical Trial Reporting Program )
U10CA180821 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Neoplasms
Central Nervous System Diseases
Nervous System Diseases