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This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early intervention group of brain radiotherapy | Experimental | the brain radiotherapy started within 1 month of almonertinib the brain radiotherapy here specifically refers to stereotactic radiotherapy |
|
| late intervention group of brain radiotherapy | Active Comparator | Brain radiotherapy was given within 3 months after brain progression during almonertinib treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brain radiotherapy | Radiation | Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The time from randomization to death from any cause. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| intracranial progression free survival | patients were randomized from the time of observation of intracranial disease progression or death from any cause | 2 years |
| progression free survival | patients were randomized from the time of observation of systemic disease progression or death from any cause |
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Inclusion Criteria:
Inclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Likun Chen, Ph.D | Contact | +8613798019964 | chenlk@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Likun Chen | sunyat-sen university cancer center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun-Yat-Sen university | Recruiting | Guangdong | Guangzhou | 510000 | China |
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|
| Almonertinib | Drug | almonertinib po 110mg QD |
|
| 2 years |
| intracranial objective response rate | proportion of patients with complete or partial response of intracranial lesions | 6 months |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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