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To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.
Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including surgery or concurrent chemoradiotherapy. EGFR is overexposed in most of the cases. In this phase II trial, the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy will be investigated in this setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib & Radiotherapy | Experimental | Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT. |
|
| Radiotherapy alone | Active Comparator | Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | 125mg, Po, TID during RT |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| incidence rates of radiation-related pneumonitis and esophagitis | within the 3 months after the initiation of RT |
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Inclusion Criteria:
Exclusion Criteria:
(1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xia, MD | Contact | 86 571 64006039 | bxia_hzch@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shixiu Wu, MD | Hangzhou Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33026449 | Derived | Luo H, Jiang W, Ma L, Chen P, Fang M, Ding L, Hua Y, Du D, Jing Z, Xie R, Song Y, Wang J, Zhou R, Tian Z, Wu S. Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019440. doi: 10.1001/jamanetworkopen.2020.19440. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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| Thoracic radiotherapy | Radiation | involved-Field irradiaton without elective nodal irradiation |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |