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Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioradiotherapy | Experimental | Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) | Drug | Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day). |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | week 3-4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0. | Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0). | year 0- year 2 |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhishuang Zheng, Dr | Contact | +8657186826086 | zhengzs19841130@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shixiu Wu, MD | Hangzhou Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | 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 |
| C531470 | icotinib |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Radiotherapy | Radiation | Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week. |
|
Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. |
| year 0- year 2 |
| Overall survival | Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death. | year 0- year 2 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013812 | Therapeutics |