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The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD |
|
| Icotinib plus radiation therapy | Experimental | Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | orally three times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival of intracranial lesions | Number of participants with progress of intracranial lesions | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Number of participants with progress of any places in body | 8 months |
| Objective response rate of intracranial lesions | Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li jiancheng | Contact | 86+13906900190 | 8613906900190 | jianchengli6@126.com |
| Li jiancheng | Contact | 8613906900190 | 8613906900190 | jianchengli6@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li jiancheng | Fujian oncology hospital | Study Director |
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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 |
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| WBRT or SRS | Radiation | >3 with WBRT;<=3 with SRS |
|
|
| 8 weeks |
| 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 |