Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, États-Unis, 85013
- Foundation for Cancer Research and Education
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Phoenix, Arizona, États-Unis, 85001-2071
- St. Joseph's Hospital and Medical Center
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California
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Concord, California, États-Unis, 94524-4110
- Mount Diablo Regional Cancer Center
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Sacramento, California, États-Unis, 95816
- Sutter Cancer Center
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San Francisco, California, États-Unis, 94115
- UCSF Comprehensive Cancer Center
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Walnut Creek, California, États-Unis, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, États-Unis, 06520-8040
- Yale Comprehensive Cancer Center
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Florida
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Gainesville, Florida, États-Unis, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Illinois
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Chicago, Illinois, États-Unis, 60612
- University of Illinois Medical Center
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Iowa
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Davenport, Iowa, États-Unis, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, États-Unis, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Michigan
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Detroit, Michigan, États-Unis, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, États-Unis, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Edison, New Jersey, États-Unis, 08818
- John F. Kennedy Medical Center
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New York
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Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, États-Unis, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, États-Unis, 28232-2861
- Carolina Neurosurgery and Spine Associates
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Durham, North Carolina, États-Unis, 27705
- American College of Surgeons Oncology Group
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Winston-Salem, North Carolina, États-Unis, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, États-Unis, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, États-Unis, 15215
- UPMC St. Margaret
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Pittsburgh, Pennsylvania, États-Unis, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
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Tennessee
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Memphis, Tennessee, États-Unis, 38104
- Methodist Cancer Center at Methodist University Hospital
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Utah
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American Fork, Utah, États-Unis, 84003
- American Fork Hospital
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- Cancer Center at the University of Virginia
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Richmond, Virginia, États-Unis, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Overall survival (OS)
Délai: Up to 6 months
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Up to 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Time to CNS failure
Délai: Up to 4 years
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Up to 4 years
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Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Délai: From baseline to up to 3 months
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From baseline to up to 3 months
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Change in the duration of functional independence using the Barthel ADL Index score
Délai: From baseline to up to 4 years
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From baseline to up to 4 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ACOSOG-Z0300
- CDR0000069183 (Autre identifiant: NCI Physician Data Query)
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