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

NCT00377156 | Completed Phase 3 Results DMC

• 5 other identifiers: N0574NCCTG-N0574ACOSOG-N0574CDR0000499633NCI-2009-00653
• Study Type: interventional
• Target: 213
• Locations: 2 countries
• Sites: 64

Brief 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. 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.

Conditions

Breast Cancer; Cognitive/Functional Effects; Lung Cancer; Metastatic Cancer; Prostate Cancer

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

Outcome Measures

Primary Outcomes (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.

  3 months post radiosurgery

Secondary Outcomes (4)

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

  Up to 3 months

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

  From Baseline to 3-Month Evaluation

• Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months

  From baseline to 12 months

• Overall Survival

  Up to 5 years

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients undergo stereotactic radiosurgery (SRS)

Radiation: stereotactic radiosurgery

Arm II

EXPERIMENTAL

Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.

Radiation: radiation therapy; Radiation: stereotactic radiosurgery

Interventions

radiation therapy RADIATION

Patients undergo radiation therapy 5 days a week for 2.5 weeks

Arm II

stereotactic radiosurgery RADIATION

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (64)

Arizona Oncology-Deer Valley Center

Phoenix, Arizona, 85027, United States

Location

Arizona Oncology Services Foundation

Scottsdale, Arizona, 85260, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Kaiser Permanente - Division of Research - Oakland

Oakland, California, 94611, United States

Location

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, 92868, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, 95403, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

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

Savannah, Georgia, 31405, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Owensboro Mercy Medical Center

Owensboro, Kentucky, 42303, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Saint Vincent Hospital at Worcester Medical Center

Worcester, Massachusetts, 01608, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, 63703, United States

Location

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

Kansas City, Missouri, 64111, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Seacoast Cancer Center at Wentworth - Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

J. Phillip Citta Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Cape Fear Valley Medical Center Cancer Center

Fayetteville, North Carolina, 28302-2000, United States

Location

Coastal Carolina Radiation Oncology Center

Wilmington, North Carolina, 28401, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Cancer Care Center, Incorporated

Salem, Ohio, 44460, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Frankford Hospital Cancer Center - Torresdale Campus

Philadelphia, Pennsylvania, 19114, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Greenville Cancer Center of the Carolinas (CCOP)

Greenville, South Carolina, 29615, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Legacy Salmon Creek Medical Center

Vancouver, Washington, 98686, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine, Wisconsin, 53405, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUS-Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

• 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.

  PMID: 28939223 DERIVED

• 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.

  PMID: 27458945 DERIVED

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Prostatic Neoplasms; Brain Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms, Male

Interventions

Radiotherapy; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Paul Brown, M.D.
• Organization: Mayo Clinic

Brown.Paul@mayo.edu

507-538-0948

Study Officials

• Paul D. Brown, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2014
• Study Completion: December 15, 2019
• Last Updated: September 16, 2022
• Results First Posted: August 24, 2017

Record last verified: 2022-09

Locations

US (60); CA (4)