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Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant Erlotinib and radiotherapy | Experimental | Patients received Erlotinib and radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib 150mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.) | After the thoracic radiotherapy and concurrent Erlotinib treatment | |
| The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) | Every one month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | The time from the start of treatment to diease progression | |
| The overall survival | The time from the start of treatment to death | |
| Quality of Life (QoL was evaluated according to the FACT-L.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenglin Ma, MD | Contact | +8657188122568 | mashenglin@medmail.com.cn | |
| Yaping Xu, MD | Contact | +8657188122082 | xuyaping1207@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shenglin Ma, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Lvhua Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Thoracic radiotherapy |
| Radiation |
60-70Gy/30-35f |
|
| Every one month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |