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 февраля 2018 г. обновлено: 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.
Обзор исследования
Статус
Прекращено
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
126
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Manitoba
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Winnipeg, Manitoba, Канада, R3E 0V9
- CancerCare Manitoba
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Ontario
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Ottawa, Ontario, Канада, K1Y 4E9
- Ottawa Hospital-Civic Campus
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Quebec
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Montreal, Quebec, Канада, H2W 1S6
- McGill University Department of Oncology
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Arizona
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Scottsdale, Arizona, Соединенные Штаты, 85260
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, Соединенные Штаты, 85260
- Scottsdale Health Care-Osborn
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California
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Burbank, California, Соединенные Штаты, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Соединенные Штаты, 90027
- Kaiser Permanente Los Angeles Medical Center
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Pomona, California, Соединенные Штаты, 91767
- Pomona Valley Hospital Medical Center
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Colorado
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Grand Junction, Colorado, Соединенные Штаты, 81501
- Saint Mary's Hospital and Regional Medical Center
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Delaware
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Newark, Delaware, Соединенные Штаты, 19718
- Christiana Care Health System-Christiana Hospital
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Florida
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Jacksonville, Florida, Соединенные Штаты, 32207
- Baptist MD Anderson Cancer Center
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Jacksonville, Florida, Соединенные Штаты, 32258
- Baptist Medical Center South
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Jacksonville, Florida, Соединенные Штаты, 32207
- Integrated Community Oncology Network-Southside Cancer Center
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Jacksonville Beach, Florida, Соединенные Штаты, 32250
- Integrated Community Oncology Network-Florida Cancer Center Beaches
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Miami, Florida, Соединенные Штаты, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orange Park, Florida, Соединенные Штаты, 32073
- 21st Century Oncology-Orange Park
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Orlando, Florida, Соединенные Штаты, 32806
- UF Cancer Center at Orlando Health
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Palatka, Florida, Соединенные Штаты, 32177
- 21st Century Oncology-Palatka
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Panama City, Florida, Соединенные Штаты, 32401
- Bay Medical Center
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Saint Augustine, Florida, Соединенные Штаты, 32086
- Integrated Community Oncology Network-Flager Cancer Center
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Tallahassee, Florida, Соединенные Штаты, 32308
- Tallahassee Memorial HealthCare
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Georgia
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Columbus, Georgia, Соединенные Штаты, 31904
- John B Amos Cancer Center
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Idaho
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Boise, Idaho, Соединенные Штаты, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Arlington Heights, Illinois, Соединенные Штаты, 60005
- Northwest Community Hospital
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Chicago, Illinois, Соединенные Штаты, 60611
- Northwestern University
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Harvey, Illinois, Соединенные Штаты, 60426
- Ingalls Memorial Hospital
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Springfield, Illinois, Соединенные Штаты, 62702
- Saint John's Hospital
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Indiana
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Fort Wayne, Indiana, Соединенные Штаты, 46805
- Parkview Hospital Randallia
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Hammond, Indiana, Соединенные Штаты, 46320
- Franciscan Saint Margaret Health-Hammond Campus
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Indianapolis, Indiana, Соединенные Штаты, 46202
- IU Health Methodist Hospital
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Iowa
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Dubuque, Iowa, Соединенные Штаты, 52001
- Finley Hospital
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40207
- Norton Suburban Hospital and Medical Campus
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21201
- University of Maryland/Greenebaum Cancer Center
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Baltimore, Maryland, Соединенные Штаты, 21229
- Saint Agnes Hospital
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Соединенные Штаты, 48201
- Wayne State University/Karmanos Cancer Institute
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Kalamazoo, Michigan, Соединенные Штаты, 49007
- West Michigan Cancer Center
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Minnesota
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Burnsville, Minnesota, Соединенные Штаты, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Соединенные Штаты, 55433
- Mercy Hospital
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Edina, Minnesota, Соединенные Штаты, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Соединенные Штаты, 55432
- Unity Hospital
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Minneapolis, Minnesota, Соединенные Штаты, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Соединенные Штаты, 55455
- University of Minnesota/Masonic Cancer Center
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Robbinsdale, Minnesota, Соединенные Штаты, 55422
- North Memorial Medical Health Center
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Saint Cloud, Minnesota, Соединенные Штаты, 56303
- Coborn Cancer Center at Saint Cloud Hospital
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Saint Cloud, Minnesota, Соединенные Штаты, 56303
- Saint Cloud Hospital
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Saint Louis Park, Minnesota, Соединенные Штаты, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Соединенные Штаты, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, Соединенные Штаты, 55102
- United Hospital
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Waconia, Minnesota, Соединенные Штаты, 55387
- Ridgeview Medical Center
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63110
- Saint Louis University Hospital
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89106
- Nevada Cancer Research Foundation CCOP
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Reno, Nevada, Соединенные Штаты, 89502
- Renown Regional Medical Center
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New Jersey
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New Brunswick, New Jersey, Соединенные Штаты, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Red Bank, New Jersey, Соединенные Штаты, 07701
- Riverview Medical Center/Booker Cancer Center
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Sparta, New Jersey, Соединенные Штаты, 07871
- Sparta Cancer Treatment Center
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New York
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Rochester, New York, Соединенные Штаты, 14642
- University of Rochester
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North Carolina
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Asheville, North Carolina, Соединенные Штаты, 28801
- Mission Hospital-Memorial Campus
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Ohio
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Akron, Ohio, Соединенные Штаты, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Cleveland, Ohio, Соединенные Штаты, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
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Pennsylvania
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Drexel Hill, Pennsylvania, Соединенные Штаты, 19026
- Delaware County Memorial Hospital
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Philadelphia, Pennsylvania, Соединенные Штаты, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Соединенные Штаты, 19103
- Radiation Therapy Oncology Group
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West Reading, Pennsylvania, Соединенные Штаты, 19611
- Reading Hospital
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29425
- Medical University of South Carolina
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Tennessee
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Knoxville, Tennessee, Соединенные Штаты, 37916
- Thompson Cancer Survival Center
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Texas
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Arlington, Texas, Соединенные Штаты, 76012
- Arlington Cancer Center
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Dallas, Texas, Соединенные Штаты, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Galveston, Texas, Соединенные Штаты, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Соединенные Штаты, 77030
- M D Anderson Cancer Center
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Utah
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Murray, Utah, Соединенные Штаты, 84107
- Intermountain Medical Center
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Ogden, Utah, Соединенные Штаты, 84403
- McKay-Dee Hospital Center
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Salt Lake City, Utah, Соединенные Штаты, 84112
- Huntsman Cancer Institute/University of Utah
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Salt Lake City, Utah, Соединенные Штаты, 84143
- LDS Hospital
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Соединенные Штаты, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Seattle, Washington, Соединенные Штаты, 98101
- Virginia Mason Medical Center
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53792
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Froedtert and The Medical College of Wisconsin
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Racine, Wisconsin, Соединенные Штаты, 53405
- Wheaton Franciscan Cancer Care - All Saints
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
|
Patients undergo radiation therapy once daily for approximately 3 weeks
Другие имена:
Patients undergo surgery after radiation therapy
Другие имена:
|
|
Экспериментальный: 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.
|
Дается устно
Другие имена:
Patients undergo radiation therapy once daily for approximately 3 weeks
Другие имена:
Patients undergo surgery after radiation therapy
Другие имена:
|
|
Экспериментальный: 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.
|
Дается устно
Другие имена:
Patients undergo radiation therapy once daily for approximately 3 weeks
Другие имена:
Patients undergo surgery after radiation therapy
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival
Временное ограничение: 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.
|
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.
|
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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rate of CNS Progression (One Year)
Временное ограничение: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
|
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.
|
From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
|
|
Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument
Временное ограничение: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
|
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).
|
From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
|
|
Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months
Временное ограничение: From randomization to three months.
|
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.
|
From randomization to three months.
|
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Change in Performance Status at Six Months
Временное ограничение: From randomization to six months.
|
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.
|
From randomization to six months.
|
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Change in Steroid Dependence at Six Months
Временное ограничение: From randomization to six months.
|
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.
|
From randomization to six months.
|
|
Cause of Death (Neurologic vs Other)
Временное ограничение: From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
|
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.
|
From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Paul Sperduto, Radiation Therapy Oncology Group
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
6 октября 2004 г.
Первичное завершение (Действительный)
14 июня 2011 г.
Завершение исследования (Действительный)
1 апреля 2012 г.
Даты регистрации исследования
Первый отправленный
9 ноября 2004 г.
Впервые представлено, что соответствует критериям контроля качества
8 ноября 2004 г.
Первый опубликованный (Оценивать)
9 ноября 2004 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 марта 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 февраля 2018 г.
Последняя проверка
1 февраля 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования по локализации
- Новообразования дыхательных путей
- Грудные новообразования
- Рак, Бронхогенный
- Бронхиальные новообразования
- Новообразования центральной нервной системы
- Новообразования нервной системы
- Новообразования
- Новообразования легких
- Карцинома немелкоклеточного легкого
- Новообразования головного мозга
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Противоопухолевые агенты
- Противоопухолевые агенты, алкилирующие
- Алкилирующие агенты
- Ингибиторы протеинкиназы
- Эрлотиниб гидрохлорид
- Темозоломид
Другие идентификационные номера исследования
- NCI-2009-00720 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
- U10CA021661 (Грант/контракт NIH США)
- CDR0000389490
- RTOG 0320 (Другой идентификатор: Radiation Therapy Oncology Group)
- RTOG-0320 (Другой идентификатор: CTEP)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .