Whole Brain Radiotherapy
Conditions
Brief summary
The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer
Detailed description
This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor progression. Efficacy and toxicity data were collected for evaluation and analysis.
Interventions
DRUGAntirotinib hydrochloride
Oral antirotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to RECIST criteria. 2. The expected survival time is more than 3 months. 3. Intracranial metastases ≤10. 4. Adequate organ and bone marrow function.
Exclusion criteria
1. Patients who have used antiangiogenic drugs within the previous 1 month. 2. Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer). 3. Small cell lung cancer with hilar invasion or hemoptysis. 4. Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage. 5. An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment. 6. Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications. 7. Patients with life-threatening conditions of other severe and/or uncontrolled diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial progression-free survival | 6 months | Time from enrollment to intracranial tumor progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 1 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. |
| progression-free survival | 6 months | The time from enrollment to tumor progression (any aspect) or death from any cause |
Countries
China
Outcome results
None listed