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. februar 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
126
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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, Forenede Stater, 85260
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, Forenede Stater, 85260
- Scottsdale Health Care-Osborn
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California
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Forenede Stater, 90027
- Kaiser Permanente Los Angeles Medical Center
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Pomona, California, Forenede Stater, 91767
- Pomona Valley Hospital Medical Center
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Colorado
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Grand Junction, Colorado, Forenede Stater, 81501
- Saint Mary's Hospital and Regional Medical Center
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Delaware
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Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health System-Christiana Hospital
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Florida
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist MD Anderson Cancer Center
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Jacksonville, Florida, Forenede Stater, 32258
- Baptist Medical Center South
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Jacksonville, Florida, Forenede Stater, 32207
- Integrated Community Oncology Network-Southside Cancer Center
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Jacksonville Beach, Florida, Forenede Stater, 32250
- Integrated Community Oncology Network-Florida Cancer Center Beaches
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Miami, Florida, Forenede Stater, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orange Park, Florida, Forenede Stater, 32073
- 21st Century Oncology-Orange Park
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Orlando, Florida, Forenede Stater, 32806
- UF Cancer Center at Orlando Health
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Palatka, Florida, Forenede Stater, 32177
- 21st Century Oncology-Palatka
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical Center
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Saint Augustine, Florida, Forenede Stater, 32086
- Integrated Community Oncology Network-Flager Cancer Center
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial HealthCare
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Georgia
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Columbus, Georgia, Forenede Stater, 31904
- John B Amos Cancer Center
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Northwest Community Hospital
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
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Springfield, Illinois, Forenede Stater, 62702
- Saint John's Hospital
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46805
- Parkview Hospital Randallia
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Hammond, Indiana, Forenede Stater, 46320
- Franciscan Saint Margaret Health-Hammond Campus
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Indianapolis, Indiana, Forenede Stater, 46202
- IU Health Methodist Hospital
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Iowa
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Dubuque, Iowa, Forenede Stater, 52001
- Finley Hospital
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Norton Suburban Hospital and Medical Campus
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
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Baltimore, Maryland, Forenede Stater, 21229
- Saint Agnes Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University/Karmanos Cancer Institute
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Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Unity Hospital
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota/Masonic Cancer Center
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Robbinsdale, Minnesota, Forenede Stater, 55422
- North Memorial Medical Health Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center at Saint Cloud Hospital
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Saint Cloud, Minnesota, Forenede Stater, 56303
- Saint Cloud Hospital
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Saint Louis University Hospital
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- Nevada Cancer Research Foundation CCOP
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Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Red Bank, New Jersey, Forenede Stater, 07701
- Riverview Medical Center/Booker Cancer Center
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Sparta, New Jersey, Forenede Stater, 07871
- Sparta Cancer Treatment Center
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospital-Memorial Campus
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Ohio
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Akron, Ohio, Forenede Stater, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
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Pennsylvania
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Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Memorial Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19103
- Radiation Therapy Oncology Group
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West Reading, Pennsylvania, Forenede Stater, 19611
- Reading Hospital
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
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Texas
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Arlington, Texas, Forenede Stater, 76012
- Arlington Cancer Center
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Galveston, Texas, Forenede Stater, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
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Utah
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Murray, Utah, Forenede Stater, 84107
- Intermountain Medical Center
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Ogden, Utah, Forenede Stater, 84403
- McKay-Dee Hospital Center
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute/University of Utah
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Salt Lake City, Utah, Forenede Stater, 84143
- LDS Hospital
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Virginia
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Norfolk, Virginia, Forenede Stater, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Medical Center
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Froedtert and The Medical College of Wisconsin
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Racine, Wisconsin, Forenede Stater, 53405
- Wheaton Franciscan Cancer Care - All Saints
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
Andre navne:
Patients undergo surgery after radiation therapy
Andre navne:
|
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Eksperimentel: 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.
|
Gives oralt
Andre navne:
Patients undergo radiation therapy once daily for approximately 3 weeks
Andre navne:
Patients undergo surgery after radiation therapy
Andre navne:
|
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Eksperimentel: 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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Gives oralt
Andre navne:
Patients undergo radiation therapy once daily for approximately 3 weeks
Andre navne:
Patients undergo surgery after radiation therapy
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of CNS Progression (One Year)
Tidsramme: 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
Tidsramme: 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.
|
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Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
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Cause of Death (Neurologic vs Other)
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Paul Sperduto, Radiation Therapy Oncology Group
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. oktober 2004
Primær færdiggørelse (Faktiske)
14. juni 2011
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
9. november 2004
Først indsendt, der opfyldte QC-kriterier
8. november 2004
Først opslået (Skøn)
9. november 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Neoplasmer i hjernen
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Proteinkinasehæmmere
- Erlotinib hydrochlorid
- Temozolomid
Andre undersøgelses-id-numre
- NCI-2009-00720 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA021661 (U.S. NIH-bevilling/kontrakt)
- CDR0000389490
- RTOG 0320 (Anden identifikator: Radiation Therapy Oncology Group)
- RTOG-0320 (Anden identifikator: CTEP)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .