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- Klinische proef NCT02556593
IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Guangdong, China, 510000
- Hui Liu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Pathologically confirmed NSCLC and wild type EGFR
- 4-10 brain metastases on high quality CT scanning or MRI.
- No previous EGFR-TKI treatment.
- No previous brain radiotherapy.
- More than 4 weeks from last chemotherapy.
- Expected Survival of at least 2 months.
- KPS≥ 70
- RTOG RPA performance status 0-1
- Lab tests should meet these criteria: White blood cell count ≥3×10^9 /L;Platelet count≥100×10^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
- Pregnancy test (-)
- Be able to sign informed consent form.
Exclusion Criteria:
- With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases)
- With metastases on meninges.
- Taking antiepileptics (phenytoin sodium etc.) at the same time
- Unable to oral medication.
- Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: IMRT & erlotinib
Patients in experimental group receive IMRT and erlotinib: Daily IMRT(45Gy in 15 fractions) to the brain metastases with daily erlotinib(150mg.po)
for three weeks
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Daily IMRT at 45 Gy in 15 fractions to brain metastases
erlotinib 150mg daily
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Actieve vergelijker: whole-brain radiotherapy
Patients in this group receive WBRT at 30Gy in 10 fractions
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3DCRT at 30 Gy in 10 fractions to whole brain
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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CNS progression free survival
Tijdsspanne: 2 years
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2 years
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Neoplasmata van het centrale zenuwstelsel
- Neoplasmata van het zenuwstelsel
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Hersenneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Erlotinibhydrochloride
Andere studie-ID-nummers
- GASTO1009
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University of Michigan Rogel Cancer CenterBeëindigdBorstkankerVerenigde Staten
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