This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain.
Adult patients (18-80 years of age) with Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance score ≥ 70, expected life time more than 6 months;
Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis). Patients with de novo or recurrent small cell lung cancer are permitted;
No more than 10 metastatic brain lesions with ≤5 cm in largest diameter and ≤150 ml in treated volume, confirmed by a high-resolution (thickness ≤2mm) , 3-dimensional T1-weighted postgadolinium magnetic resonance imaging (MRI) brain scan within 2 weeks of study initiation. All brain metastases must be outside a 5-mm margin around either hippocampus or optic pathways.
Not all metastatic brain lesions are recommended or suitable for surgical resection after multidisciplinary team discussion. If part of metastatic brain lesions are resected, the patient is permitted for enrollment evaluation at least two weeks after resection; 5 Patients must have the psychological ability and general health that permits completion of the study requirements, all assessment (HVLT-R, MoCA, EORTC QLQ-C30) and required follow up (at least 6 months);
Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration;
Previous radiotherapy of the brain;
Patients can not tolerate immobilization or are with MRI contraindication (i.e., cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants);
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases, increased intracranial pressure requiring immediate depression surgery.
Parallel
Experimental group (SRS/SRT/Hypo-RT)
Combination productThe prescription dose of SRS/SRT is 18-22Gy in 1 fraction, 27Gy in 3 fractions and 30Gy in 5 fractions. The prescription dose of Hypo-RT is 40Gy in 8 fraction. The prescription dose could be adjusted if lesions are located in brain stem when treat with SRS/SRT/Hypo-RT.
Controled group (HA-WBRT)
RadiationThe prescription dose of HA-WBRT is 30Gy in 10 fraction.
Cognitive function scores
Hopkins Verbal Learning Test-Revised (HVLT-R) total recall score at 6 months after radiotherapy
Meadian OS time
The time that half of enrolled patients died.
Cognitive function scores
The Montreal cognitive assessment (MoCA) score at 3 ,6,9,12 months after radiotherapy
Scores of quality of life
The European organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) score at 3,6,9,12 months after radiotherapy
The time of neurological progression free survival
The time that ≥3 points reduced of HVLT-R total recall score or MoCA score after radiotherapy
The time of intracranial overall progression free survival
The time that half of enrolled patients had intracranial relapse
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