Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anlotinib, Whole-brain Radiotherapy.
- Who it may be relevant to
- Registry conditions: Whole-Brain Radiotherapy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.
Overview
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
- Drug Anlotinib
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 - Radiation Whole-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.
Primary outcome measures
- Intracranial progression-free survival [Time frame: 1 year]
Secondary outcome measures (4)
- Intracranial objective response rate (ORR) and disease control rate (DCR) [Time frame: 1 year]
- Duration of intracranial response (DOR) [Time frame: 1 year]
- Overall Survival (OS) [Time frame: 2 year]
- CTCs level [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Unio — Beijing
Identifiers
NCT: NCT07443397 · NCC5213