Whole-Brain Radiotherapy
Conditions
Brief summary
This study is a multicenter, randomized, prospective Phase III study to evaluate the efficacy and safety of anlotinib plus whole-brain radiotherapy (WBRT) compared with WBRT alone in small cell lung cancer (SCLC) patients with brain metastases. Additionally, by investigating the association between changes in circulating tumor cell (CTC) levels in peripheral blood and treatment response to the combination of targeted therapy and radiotherapy, we aim to identify a patient subgroup most likely to benefit from this regimen, as well as potential biomarkers predictive of treatment efficacy.
Interventions
DRUGAnlotinib
Oral anlotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression
RADIATIONWhole-brain Radiotherapy
Prescription dose: Whole-brain irradiation with a minimum of 30 Gy in 10 fractions or 36 Gy in 20 fractions. Lesions larger than 5 mm in diameter may receive a simultaneous or sequential boost.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Small cell lung cancer confirmed by pathology, with brain metastases diagnosed either at initial presentation or during treatment, and measurable disease according to RECIST criteria. * The expected survival time is more than 3 months. * Intracranial metastases ≤10. * Adequate organ and bone marrow function. * Women of childbearing potential must agree to use effective contraception during the study and for 6 months after its completion.
Exclusion criteria
* Patients who have used antiangiogenic drugs within the previous 1 month. * Non-small cell lung cancer (including combined small cell carcinoma). * Small cell lung cancer with hilar invasion or hemoptysis. * Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage. * An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment. * Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications. * Patients with life-threatening conditions of other severe and/or uncontrolled diseases. * History of prior brain radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial progression-free survival | 1 year | Time from enrollment to intracranial tumor progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial objective response rate (ORR) and disease control rate (DCR) | 1 year | ORR (Objective Response Rate): The proportion of patients whose tumors shrink significantly (either completely or partially) after treatment. DCR (Disease Control Rate): The proportion of patients whose tumors either shrink or remain stable (i.e., do not progress) after treatment. |
| Duration of intracranial response (DOR) | 1 year | The length of time from when a patient first achieves tumor response (CR or PR) until disease progression or death. |
| Overall Survival (OS) | 2 year | The time from enrollment to death from any cause was calculated as the time of death. For participants who were lost to follow-up, the time of death was usually the time of the last follow-up. |
| CTCs level | 1 year | Levels of circulating tumor cells (CTCs) in peripheral blood. |
Countries
China
Contacts
CONTACTLei Deng, MD
STUDY_CHAIRLei Deng, MD
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Outcome results
None listed