Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
NCT ID: NCT02215356
Last Updated: 2014-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2014-08-31
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoradiotherapy
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.
Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Icotinib with concurrent radiotherapy
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.
Icotinib with concurrent radiotherapy
Icotinib: 125 mg is administered orally three times per day.
Interventions
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Icotinib with concurrent radiotherapy
Icotinib: 125 mg is administered orally three times per day.
Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous systemic anticancer therapy
* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
* ECOG Performance Status of 0 to 1
Exclusion Criteria
* Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
* Known severe hypersensitivity to icotinib or any of the excipients of this product
18 Years
75 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lvhua Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xiaolong Fu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
People's Liberation Army 307 Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Union Medical College Hospital
Beijing, Beijing Municipality, China
Dongguan City People's Hospital
Dongguan, Guangdong, China
Sun Yat-sen Cancer Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China
Tumor Hospital of Jilin Province
Changchun, Jilin, China
Liaoning Provincial Tumor Hospital
Shenyang, Liaoning, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanxi Tumor Hospital
Taiyuan, Shanxi, China
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Tumor Hospital of Yunnan Province
Kunming, Yunnan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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BD-IC-IV66
Identifier Type: -
Identifier Source: org_study_id
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