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This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib 375mg Tid | Experimental | The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | 375 mg Tid (1125 mg per day) until intracranial PD. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| intracranial progression-free survival | from date of randomization until the date of first documented intracranial progression, assessed up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| progress-free survival | from date of randomization until the date of extracranial progression, assessed up to 18 months. | |
| overall survival | from date of randomization until the date of death, assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by NCI-CJ-CAE3.0 | from date of randomization until the date of death, assessed up to 2 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YOU LU, M.D. | Contact | 0086-28-85423571 | radyoulu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| YOU LU, M.D. | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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| SRS |
| Radiation |
If intracranial PD, then the subjects get stereotatic radiosurgery (30Gy/3f) combined with Icotinib 375mg Tid. |
|
| objective response rate | from date of randomization until the date of progression, assessed up to 12 months. |
| disease control rate | from date of randomization until the date of progression, assessed up to 18 months. |
| Quality of life measured by FACT-L/LCS 4.0 and FACT-Br | from date of randomization until the date of death from any cause, assessed up to 36 months. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |