Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer
9 février 2018 mis à jour par: National Cancer Institute (NCI)
A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer.
Radiation therapy uses high-energy x-rays to kill tumor cells.
Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.
Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die.
Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor.
It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
I. Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or erlotinib.
SECONDARY OBJECTIVES:
I. Compare time to CNS progression in patients treated with these regimens. II. Compare quality-adjusted survival in patients treated with these regimens. III. Compare 3-month quality of life in patients treated with these regimens. IV. Compare the 6-month performance status of patients treated with these regimens.
V. Compare 6-month steroid dependence in patients treated with these regimens. VI. Compare cause of death (neurologic vs other) in patients treated with these regimens.
VII. Determine the effects of non-protocol chemotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and the presence of extracranial metastases (< 65 years old AND no extracranial metastases vs ≥ 65 years old OR extracranial metastases), number of metastases (1 vs 2 or 3), and extent of extracranial disease (none vs present). Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
ARM II: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM III: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
In all arms, patients with recurrent brain metastases may undergo additional stereotactic radiosurgery.
Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Type d'étude
Interventionnel
Inscription (Réel)
126
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- Ottawa Hospital-Civic Campus
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University Department of Oncology
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Arizona
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Scottsdale, Arizona, États-Unis, 85260
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, États-Unis, 85260
- Scottsdale Health Care-Osborn
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California
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, États-Unis, 90027
- Kaiser Permanente Los Angeles Medical Center
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Pomona, California, États-Unis, 91767
- Pomona Valley Hospital Medical Center
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Colorado
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Grand Junction, Colorado, États-Unis, 81501
- Saint Mary's Hospital and Regional Medical Center
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Delaware
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Newark, Delaware, États-Unis, 19718
- Christiana Care Health System-Christiana Hospital
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Florida
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Jacksonville, Florida, États-Unis, 32207
- Baptist MD Anderson Cancer Center
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Jacksonville, Florida, États-Unis, 32258
- Baptist Medical Center South
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Jacksonville, Florida, États-Unis, 32207
- Integrated Community Oncology Network-Southside Cancer Center
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Jacksonville Beach, Florida, États-Unis, 32250
- Integrated Community Oncology Network-Florida Cancer Center Beaches
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Miami, Florida, États-Unis, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orange Park, Florida, États-Unis, 32073
- 21st Century Oncology-Orange Park
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Orlando, Florida, États-Unis, 32806
- UF Cancer Center at Orlando Health
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Palatka, Florida, États-Unis, 32177
- 21st Century Oncology-Palatka
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Panama City, Florida, États-Unis, 32401
- Bay Medical Center
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Saint Augustine, Florida, États-Unis, 32086
- Integrated Community Oncology Network-Flager Cancer Center
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Tallahassee, Florida, États-Unis, 32308
- Tallahassee Memorial HealthCare
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Georgia
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Columbus, Georgia, États-Unis, 31904
- John B Amos Cancer Center
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Idaho
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Boise, Idaho, États-Unis, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Arlington Heights, Illinois, États-Unis, 60005
- Northwest Community Hospital
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Harvey, Illinois, États-Unis, 60426
- Ingalls Memorial Hospital
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Springfield, Illinois, États-Unis, 62702
- Saint John's Hospital
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Indiana
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Fort Wayne, Indiana, États-Unis, 46805
- Parkview Hospital Randallia
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Hammond, Indiana, États-Unis, 46320
- Franciscan Saint Margaret Health-Hammond Campus
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Indianapolis, Indiana, États-Unis, 46202
- IU Health Methodist Hospital
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Iowa
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Dubuque, Iowa, États-Unis, 52001
- Finley Hospital
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Kentucky
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Louisville, Kentucky, États-Unis, 40207
- Norton Suburban Hospital and Medical Campus
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland/Greenebaum Cancer Center
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Baltimore, Maryland, États-Unis, 21229
- Saint Agnes Hospital
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, États-Unis, 48201
- Wayne State University/Karmanos Cancer Institute
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Kalamazoo, Michigan, États-Unis, 49007
- West Michigan Cancer Center
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Minnesota
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy Hospital
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Edina, Minnesota, États-Unis, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, États-Unis, 55432
- Unity Hospital
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Minneapolis, Minnesota, États-Unis, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota/Masonic Cancer Center
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Robbinsdale, Minnesota, États-Unis, 55422
- North Memorial Medical Health Center
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Saint Cloud, Minnesota, États-Unis, 56303
- Coborn Cancer Center at Saint Cloud Hospital
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Saint Cloud, Minnesota, États-Unis, 56303
- Saint Cloud Hospital
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, États-Unis, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- Saint Louis University Hospital
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Nevada
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Las Vegas, Nevada, États-Unis, 89106
- Nevada Cancer Research Foundation CCOP
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Reno, Nevada, États-Unis, 89502
- Renown Regional Medical Center
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New Jersey
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New Brunswick, New Jersey, États-Unis, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Red Bank, New Jersey, États-Unis, 07701
- Riverview Medical Center/Booker Cancer Center
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Sparta, New Jersey, États-Unis, 07871
- Sparta Cancer Treatment Center
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester
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North Carolina
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Asheville, North Carolina, États-Unis, 28801
- Mission Hospital-Memorial Campus
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Ohio
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Akron, Ohio, États-Unis, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
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Pennsylvania
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Drexel Hill, Pennsylvania, États-Unis, 19026
- Delaware County Memorial Hospital
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, États-Unis, 19103
- Radiation Therapy Oncology Group
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West Reading, Pennsylvania, États-Unis, 19611
- Reading Hospital
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Tennessee
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Knoxville, Tennessee, États-Unis, 37916
- Thompson Cancer Survival Center
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Texas
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Arlington, Texas, États-Unis, 76012
- Arlington Cancer Center
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Dallas, Texas, États-Unis, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Galveston, Texas, États-Unis, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, États-Unis, 77030
- M D Anderson Cancer Center
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Utah
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Murray, Utah, États-Unis, 84107
- Intermountain Medical Center
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Ogden, Utah, États-Unis, 84403
- McKay-Dee Hospital Center
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Salt Lake City, Utah, États-Unis, 84112
- Huntsman Cancer Institute/University of Utah
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Salt Lake City, Utah, États-Unis, 84143
- LDS Hospital
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Virginia
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Norfolk, Virginia, États-Unis, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Seattle, Washington, États-Unis, 98101
- Virginia Mason Medical Center
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, États-Unis, 53226
- Froedtert and The Medical College of Wisconsin
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Racine, Wisconsin, États-Unis, 53405
- Wheaton Franciscan Cancer Care - All Saints
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer
One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
- Well circumscribed tumor(s)
Maximum diameter ≤ 4.0 cm
- If multiple lesions are present and one lesion is at the maximum diameter, the other lesions must not exceed 3.0 cm in maximum diameter
- No metastases within 10 mm of the optic apparatus such that a portion of the optic nerve or chiasm would be included in the high-dose stereotactic radiosurgery boost field
- No metastases in the brainstem, midbrain, pons, or medulla
No prior complete resection of all known brain metastases
- Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter
No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month
- Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease
Stable extracranial metastases allowed
- No known or pre-existing liver metastases
- No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
- Synchronous brain metastases at initial diagnosis allowed
- Performance status - Zubrod 0-1
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- AST < 2 times upper limit of normal (ULN)
- Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases
- Total bilirubin normal
- Lactic dehydrogenase < 2 times ULN
- Creatinine < 1.5 times ULN
No clinically active interstitial lung disease
- Chronic stable asymptomatic radiographic changes allowed
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- Neurologic function status 0-2
- No other major medical illness or psychiatric impairment that would preclude study participation
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to erlotinib or temozolomide
- No concurrent immunotherapy
- No concurrent biologic therapy, excluding growth factors and epoetin alfa
- No prior temozolomide or erlotinib
No other concurrent chemotherapy during study radiotherapy
Other concurrent chemotherapy allowed after study radiotherapy, except for the following:
- Temozolomide or erlotinib (arm I only)
- Erlotinib (arm II only)
- Temozolomide (arm III only)
- No prior cranial radiotherapy
- No concurrent intensity-modulated radiotherapy
Concurrent radiotherapy to painful bone lesions allowed
- No concurrent radiotherapy to more than 15% of bone marrow
- No other concurrent therapy for brain metastases unless a recurrence is detected
- More than 30 days since prior investigational drugs
No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following (for patients randomized to receive erlotinib):
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Primidone
- Oxcarbazepine
- No other concurrent investigational drugs
- No concurrent Hypericum perforatum (St. John's wort)
- No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within 4 hours after erlotinib administration (arm III patients only)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
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Comparateur actif: Arm I
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19.
Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
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Patients undergo radiation therapy once daily for approximately 3 weeks
Autres noms:
Patients undergo surgery after radiation therapy
Autres noms:
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Expérimental: Arm II
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21.
Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5.
Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Donné oralement
Autres noms:
Patients undergo radiation therapy once daily for approximately 3 weeks
Autres noms:
Patients undergo surgery after radiation therapy
Autres noms:
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Expérimental: Arm III
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
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Donné oralement
Autres noms:
Patients undergo radiation therapy once daily for approximately 3 weeks
Autres noms:
Patients undergo surgery after radiation therapy
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Survival
Délai: From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method.
Patients last known to be alive are censored at date of last contact.
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From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of CNS Progression (One Year)
Délai: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression).
For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression.
This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes.
For greater than 1 cm lesions, the definition uses a 25% rule for change.
Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.
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From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument
Délai: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition.
The QALY model is QALY(h,y) where h is a health state and y is the years of life.
Higher quality-adjusted life year values represent a better outcome.
A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival.
The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme).
The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).
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From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months
Délai: From randomization to three months.
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The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer.
It is to be administered with the FACT-General.
There are 5 responses options, with 0=Not a lot and 4=Very much.
All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%.
If items are missing, the subscale scores can be prorated.
A higher score indicates better QOL.
A change of 5 points will be considered a minimal clinically meaningful change.
Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.
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From randomization to three months.
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Change in Performance Status at Six Months
Délai: From randomization to six months.
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Compared between two treatment arms using a two-group chi-squared test.
Zubrod score will be collected at baseline and follow-up.
The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death.
Change from baseline is calculated as 6-month value - baseline value.
Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.
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From randomization to six months.
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Change in Steroid Dependence at Six Months
Délai: From randomization to six months.
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Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg.
Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.
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From randomization to six months.
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Cause of Death (Neurologic vs Other)
Délai: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Patients were considered to have died neurologic deaths (coded as "Brain Metastases") if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis.
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From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul Sperduto, Radiation Therapy Oncology Group
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 octobre 2004
Achèvement primaire (Réel)
14 juin 2011
Achèvement de l'étude (Réel)
1 avril 2012
Dates d'inscription aux études
Première soumission
9 novembre 2004
Première soumission répondant aux critères de contrôle qualité
8 novembre 2004
Première publication (Estimation)
9 novembre 2004
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 mars 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 février 2018
Dernière vérification
1 février 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies des voies respiratoires
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs du système nerveux central
- Tumeurs du système nerveux
- Tumeurs
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Tumeurs cérébrales
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Inhibiteurs de protéine kinase
- Chlorhydrate d'erlotinib
- Témozolomide
Autres numéros d'identification d'étude
- NCI-2009-00720 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- U10CA021661 (Subvention/contrat des NIH des États-Unis)
- CDR0000389490
- RTOG 0320 (Autre identifiant: Radiation Therapy Oncology Group)
- RTOG-0320 (Autre identifiant: CTEP)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .