A prospective, randomized, controlled clinical study of whole brain with organs at risk protection and simultaneous integrated boost versus stereotactic radiotherapy for non-small cell lung cancer brain metastases.

Not Applicable

Recruiting

• Conditions: Non-small cell lung cancer brain metastasis

• Registration Number: ChiCTR2400080236
• Lead Sponsor: Sun Yat sen University Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Histologically or cytologically confirmed NSCLC<br>2. Brain metastases confirmed by gadolinium contrast-enhanced MRI or pathological histology<br>3. Brain metastasis outside a 5-mm margin around either hippocampus<br>4. At least 1 and not exceeding 10 brain metastases, and the diameter of metastases is =5mm<br>5. Patients may have previously undergone surgical resection of brain metastases, which was completed at least 14 days prior to registration<br>6. Life expectancy of = 6 months<br>7. Palliative radiotherapy<br>8. Age =18 years at the time of consent<br>9. Karnofsky Performance Status (KPS) = 60<br>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)<br>11. Adequate liver function: Total bilirubin = 2.5 mg/dL (43 umol/L)<br>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<br>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

1. Prior radiotherapy to the brain<br>2. Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt<br>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. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol<br>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<br>5. Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per month for the past 2 months<br>6. Patients with definitive leptomeningeal metastases<br>7. Contraindication to magnetic resonance imaging (MRI) such as implanted metal devices or foreign bodies or severe claustrophobia<br>8. Contraindication to gadolinium contrast administration during MRI, such as allergy or insufficient renal function<br>9. History of malignancies other than NSCLC within 5 years<br>10. A history of/Current drug or alcohol abuse<br>11. Medical illnesses or psychiatric impairments which would prevent completion of protocol therapy<br>12. Severe coagulopathy;<br>13. Brain metastases located in the brainstem, or < 5mm from the brainstem, optic nerve, or optic chiasm;<br>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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year local tumor control rate;Intracranial Progress Free Survival;

Secondary Outcome Measures

Name	Time	Method
Cognitive impairment;Cumulative incidence of local tumor progression;Cumulative incidence of intracranial distant tumor progression;overall survival;Quality of life;Adverse effects;