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. února 2018 aktualizováno: 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.
Přehled studie
Postavení
Ukončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
126
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
-
-
Ontario
-
Ottawa, Ontario, Kanada, K1Y 4E9
- Ottawa Hospital-Civic Campus
-
-
Quebec
-
Montreal, Quebec, Kanada, H2W 1S6
- McGill University Department of Oncology
-
-
-
-
Arizona
-
Scottsdale, Arizona, Spojené státy, 85260
- Arizona Oncology Services Foundation
-
Scottsdale, Arizona, Spojené státy, 85260
- Scottsdale Health Care-Osborn
-
-
California
-
Burbank, California, Spojené státy, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
-
Los Angeles, California, Spojené státy, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Pomona, California, Spojené státy, 91767
- Pomona Valley Hospital Medical Center
-
-
Colorado
-
Grand Junction, Colorado, Spojené státy, 81501
- Saint Mary's Hospital and Regional Medical Center
-
-
Delaware
-
Newark, Delaware, Spojené státy, 19718
- Christiana Care Health System-Christiana Hospital
-
-
Florida
-
Jacksonville, Florida, Spojené státy, 32207
- Baptist MD Anderson Cancer Center
-
Jacksonville, Florida, Spojené státy, 32258
- Baptist Medical Center South
-
Jacksonville, Florida, Spojené státy, 32207
- Integrated Community Oncology Network-Southside Cancer Center
-
Jacksonville Beach, Florida, Spojené státy, 32250
- Integrated Community Oncology Network-Florida Cancer Center Beaches
-
Miami, Florida, Spojené státy, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Orange Park, Florida, Spojené státy, 32073
- 21st Century Oncology-Orange Park
-
Orlando, Florida, Spojené státy, 32806
- UF Cancer Center at Orlando Health
-
Palatka, Florida, Spojené státy, 32177
- 21st Century Oncology-Palatka
-
Panama City, Florida, Spojené státy, 32401
- Bay Medical Center
-
Saint Augustine, Florida, Spojené státy, 32086
- Integrated Community Oncology Network-Flager Cancer Center
-
Tallahassee, Florida, Spojené státy, 32308
- Tallahassee Memorial HealthCare
-
-
Georgia
-
Columbus, Georgia, Spojené státy, 31904
- John B Amos Cancer Center
-
-
Idaho
-
Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
-
Illinois
-
Arlington Heights, Illinois, Spojené státy, 60005
- Northwest Community Hospital
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University
-
Harvey, Illinois, Spojené státy, 60426
- Ingalls Memorial Hospital
-
Springfield, Illinois, Spojené státy, 62702
- Saint John's Hospital
-
-
Indiana
-
Fort Wayne, Indiana, Spojené státy, 46805
- Parkview Hospital Randallia
-
Hammond, Indiana, Spojené státy, 46320
- Franciscan Saint Margaret Health-Hammond Campus
-
Indianapolis, Indiana, Spojené státy, 46202
- IU Health Methodist Hospital
-
-
Iowa
-
Dubuque, Iowa, Spojené státy, 52001
- Finley Hospital
-
-
Kentucky
-
Louisville, Kentucky, Spojené státy, 40207
- Norton Suburban Hospital and Medical Campus
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21201
- University of Maryland/Greenebaum Cancer Center
-
Baltimore, Maryland, Spojené státy, 21229
- Saint Agnes Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Ann Arbor, Michigan, Spojené státy, 48109
- University Of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, Spojené státy, 48201
- Wayne State University/Karmanos Cancer Institute
-
Kalamazoo, Michigan, Spojené státy, 49007
- West Michigan Cancer Center
-
-
Minnesota
-
Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy Hospital
-
Edina, Minnesota, Spojené státy, 55435
- Fairview-Southdale Hospital
-
Fridley, Minnesota, Spojené státy, 55432
- Unity Hospital
-
Minneapolis, Minnesota, Spojené státy, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Spojené státy, 55455
- University of Minnesota/Masonic Cancer Center
-
Robbinsdale, Minnesota, Spojené státy, 55422
- North Memorial Medical Health Center
-
Saint Cloud, Minnesota, Spojené státy, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Cloud, Minnesota, Spojené státy, 56303
- Saint Cloud Hospital
-
Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Spojené státy, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
-
Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
-
-
Missouri
-
Saint Louis, Missouri, Spojené státy, 63110
- Saint Louis University Hospital
-
-
Nevada
-
Las Vegas, Nevada, Spojené státy, 89106
- Nevada Cancer Research Foundation CCOP
-
Reno, Nevada, Spojené státy, 89502
- Renown Regional Medical Center
-
-
New Jersey
-
New Brunswick, New Jersey, Spojené státy, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Red Bank, New Jersey, Spojené státy, 07701
- Riverview Medical Center/Booker Cancer Center
-
Sparta, New Jersey, Spojené státy, 07871
- Sparta Cancer Treatment Center
-
-
New York
-
Rochester, New York, Spojené státy, 14642
- University of Rochester
-
-
North Carolina
-
Asheville, North Carolina, Spojené státy, 28801
- Mission Hospital-Memorial Campus
-
-
Ohio
-
Akron, Ohio, Spojené státy, 44304
- Summa Akron City Hospital/Cooper Cancer Center
-
Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Foundation
-
-
Oklahoma
-
Tulsa, Oklahoma, Spojené státy, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
-
-
Pennsylvania
-
Drexel Hill, Pennsylvania, Spojené státy, 19026
- Delaware County Memorial Hospital
-
Philadelphia, Pennsylvania, Spojené státy, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Spojené státy, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Spojené státy, 19103
- Radiation Therapy Oncology Group
-
West Reading, Pennsylvania, Spojené státy, 19611
- Reading Hospital
-
-
South Carolina
-
Charleston, South Carolina, Spojené státy, 29425
- Medical University of South Carolina
-
-
Tennessee
-
Knoxville, Tennessee, Spojené státy, 37916
- Thompson Cancer Survival Center
-
-
Texas
-
Arlington, Texas, Spojené státy, 76012
- Arlington Cancer Center
-
Dallas, Texas, Spojené státy, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Galveston, Texas, Spojené státy, 77555-0565
- University of Texas Medical Branch
-
Houston, Texas, Spojené státy, 77030
- M D Anderson Cancer Center
-
-
Utah
-
Murray, Utah, Spojené státy, 84107
- Intermountain Medical Center
-
Ogden, Utah, Spojené státy, 84403
- McKay-Dee Hospital Center
-
Salt Lake City, Utah, Spojené státy, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Spojené státy, 84143
- LDS Hospital
-
-
Virginia
-
Norfolk, Virginia, Spojené státy, 23507
- Sentara Norfolk General Hospital
-
Richmond, Virginia, Spojené státy, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Spojené státy, 98101
- Virginia Mason Medical Center
-
-
Wisconsin
-
Madison, Wisconsin, Spojené státy, 53792
- University of Wisconsin Hospital and Clinics
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Froedtert and The Medical College of Wisconsin
-
Racine, Wisconsin, Spojené státy, 53405
- Wheaton Franciscan Cancer Care - All Saints
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
Ostatní jména:
Patients undergo surgery after radiation therapy
Ostatní jména:
|
|
Experimentální: 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.
|
Podáno ústně
Ostatní jména:
Patients undergo radiation therapy once daily for approximately 3 weeks
Ostatní jména:
Patients undergo surgery after radiation therapy
Ostatní jména:
|
|
Experimentální: 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.
|
Podáno ústně
Ostatní jména:
Patients undergo radiation therapy once daily for approximately 3 weeks
Ostatní jména:
Patients undergo surgery after radiation therapy
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rate of CNS Progression (One Year)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
|
Change in Performance Status at Six Months
Časové okno: 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.
|
|
Change in Steroid Dependence at Six Months
Časové okno: 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)
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Paul Sperduto, Radiation Therapy Oncology Group
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
6. října 2004
Primární dokončení (Aktuální)
14. června 2011
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
9. listopadu 2004
První předloženo, které splnilo kritéria kontroly kvality
8. listopadu 2004
První zveřejněno (Odhad)
9. listopadu 2004
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. března 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. února 2018
Naposledy ověřeno
1. února 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Nemoci dýchacích cest
- Plicní onemocnění
- Novotvary podle místa
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary centrálního nervového systému
- Novotvary nervového systému
- Novotvary
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Novotvary mozku
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antineoplastická činidla
- Antineoplastická činidla, Alkylační
- Alkylační činidla
- Inhibitory proteinkinázy
- Erlotinib hydrochlorid
- Temozolomid
Další identifikační čísla studie
- NCI-2009-00720 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- U10CA021661 (Grant/smlouva NIH USA)
- CDR0000389490
- RTOG 0320 (Jiný identifikátor: Radiation Therapy Oncology Group)
- RTOG-0320 (Jiný identifikátor: CTEP)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .