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This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiotherapy | Active Comparator | Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily. |
|
| Icotinib with concurrent radiotherapy | Experimental | Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib with concurrent radiotherapy | Drug | Icotinib: 125 mg is administered orally three times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 36 months | |
| Objective response rate | 8 weeks | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lvhua Wang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Xiaolong Fu, MD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Beijing Municipality | 100021 | China | ||
| People's Liberation Army 307 Hospital |
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| Chemoradiotherapy | Drug | Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles |
|
|
| 54 months |
| Beijing |
| Beijing Municipality |
| 100039 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Beijing Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Dongguan City People's Hospital | Dongguan | Guangdong | 523059 | China |
| Sun Yat-sen Cancer Hospital | Guangzhou | Guangdong | 510060 | China |
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| Guangxi Zhuang Autonomous Region People's Hospital | Nanning | Guangxi | 530021 | China |
| Cancer Hospital of Harbin Medical University | Harbin | Heilongjiang | 150081 | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
| Hunan Provincial Tumor Hospital | Changsha | Hunan | 410013 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| Nantong Tumor Hospital | Nantong | Jiangsu | 226361 | China |
| Jiangxi Provincial Cancer Hospital | Nanchang | Jiangxi | 330029 | China |
| Tumor Hospital of Jilin Province | Changchun | Jilin | 130012 | China |
| Liaoning Provincial Tumor Hospital | Shenyang | Liaoning | 110042 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Shanxi Tumor Hospital | Taiyuan | Shanxi | 030013 | China |
| Sichuan Provincial Tumor Hospital | Chengdu | Sichuan | 610041 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830000 | China |
| Tumor Hospital of Yunnan Province | Kunming | Yunnan | 650118 | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | 310006 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C531470 | icotinib |
| D059248 | Chemoradiotherapy |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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