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.
Small cell lung cancer (SCLC) is the most aggressive histologic subtype of lung cancer, with a predilection for early metastases. Brain metastases (BM) are a significant threat to quality of life in patients with SCLC. Stereotactic radiosurgery (SRS)/ Stereotactic Radiotherapy (SRT) is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to the surrounding normal tissue. Thus SRS/SRT has now emerged as the preferred treatment modality, either alone or in combination with other modalities for BM. However, given the propensity for dissemination of SCLC, SRS/SRT does not appear to be a rational approach to this pathology. Recently, in selected patients, whole brain radiotherapy (WBRT) has been omitted from the initial management for BM with the aim of reducing the potential risk of delayed neurological toxicity\[1-3\]. Thus, the role of upfront focal treatment by means of SRS for BM from SCLC has yet to be determined This phase III trial compares the effect of upfront local treatment (including SRS/SRT and hypofractionated radiotherapy \[Hypo-RT\]) and WBRT that avoids the hippocampus (the memory zone of the brain) for the treatment of no more than 10 BM in SCLC patients. The expectation is that SRS/SRT/Hypo-RT will be one of standard upfront local treatments in SCLC patients with no more than 10 BM. Eligible patients will be 1:1 randomized to receive ether local treatment (SRS/SRT/Hypo-RT), or hippocampal-voidance WBRT. The 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 of HA-WBRT is 30Gy in 10 fraction. The prescription dose could be adjusted if lesions are located in brain stem when treat with SRS/SRT/Hypo-RT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
340
The 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.
The prescription dose of HA-WBRT is 30Gy in 10 fraction.
Nan Bi
Beijing, Beijing Municipality, China
RECRUITINGCognitive function scores
Hopkins Verbal Learning Test-Revised (HVLT-R) total recall score at 6 months after radiotherapy
Time frame: At 6 months after radiotherapy.
Meadian OS time
The time that half of enrolled patients died.
Time frame: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
Cognitive function scores
The Montreal cognitive assessment (MoCA) score at 3 ,6,9,12 months after radiotherapy
Time frame: Measured at months 3, 6, 9, 12months 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
Time frame: Measured at months 3, 6, 9, 12months 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
Time frame: Measured at months 3, 6, 9, 12months after radiotherapy
The time of intracranial overall progression free survival
The time that half of enrolled patients had intracranial relapse
Time frame: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
The time of overall progression free survival
The time that half of enrolled patients had relapse
Time frame: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
The rate and grade of treatment related toxicity
All adverse events of enrolled patients after radiotherapy evaluated by CTCAE 5.0
Time frame: Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
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