Non-small cell lung cancer brain metastasis
Conditions
Interventions
SMART-brain:Whole brain radiotherapy for organs at-risk protection and simultaneous intefrated boost
SRT:stereotactic radiotherapy
Sponsors
Sun Yat sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed NSCLC 2. Brain metastases confirmed by gadolinium contrast-enhanced MRI or pathological histology 3. Brain metastasis outside a 5-mm margin around either hippocampus 4. At least 1 and not exceeding 10 brain metastases, and the diameter of metastases is =5mm 5. Patients may have previously undergone surgical resection of brain metastases, which was completed at least 14 days prior to registration 6. Life expectancy of = 6 months 7. Palliative radiotherapy 8. Age =18 years at the time of consent 9. Karnofsky Performance Status (KPS) = 60 10. Adequate renal function: Serum creatinine =3mg/dL (265 µmol/L) and creatinine clearance must be = 30 ml/min;Blood urea nitrogen (BUN) within institutional upper limit of normal (e.g. < 20 mg/dL) 11. Adequate liver function: Total bilirubin = 2.5 mg/dL (43 umol/L) 12. Negative serum pregnancy test (in women of childbearing potential) = 14 days prior to radiotherapy, women of childbearing potential and men who are sexually active must practice adequate contraception while on study 13. Adequate hematological function: white blood cells = 4×109/L, Absolute neutrophil count (ANC) =1.5 x 10^9/L, Hemoglobin =10 g/dL, and Platelet count =100 x 10^9/L.
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to the brain 2. Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt 3. Severe, active co-morbidity defined as follows: • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months • Transmural myocardial infarction within the last 6 months • Uncontrolled, clinically significant cardiac arrhythmias • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration • Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of registration • Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease • Renal tubular acidosis or metabolic acidosis • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count = 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol 4. Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception 5. Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per month for the past 2 months 6. Patients with definitive leptomeningeal metastases 7. Contraindication to magnetic resonance imaging (MRI) such as implanted metal devices or foreign bodies or severe claustrophobia 8. Contraindication to gadolinium contrast administration during MRI, such as allergy or insufficient renal function 9. History of malignancies other than NSCLC within 5 years 10. A history of/Current drug or alcohol abuse 11. Medical illnesses or psychiatric impairments which would prevent completion of protocol therapy 12. Severe coagulopathy; 13. Brain metastases located in the brainstem, or < 5mm from the brainstem, optic nerve, or optic chiasm; 14.Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year local tumor control rate;Intracranial Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive impairment;Cumulative incidence of local tumor progression;Cumulative incidence of intracranial distant tumor progression;overall survival;Quality of life;Adverse effects; | — |
Countries
China
Contacts
Public ContactChen Yuanyuan
Sun Yat sen University Cancer Center
Outcome results
None listed