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The main purpose of this study is to evaluate the relapse free survival of patients who have EGFR-mutant stage IIIA-IIIB Non-small Cell Lung Cancer and receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy.
This is a single center, single arm, open label and prospective clinical study. Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy. The primary objective of this study is relapse free survival. The secondary objectives are overall survival, the frequency of adverse events and patients' quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Patients with EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival of participants | Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of participants | Overall survival was defined as the time from participants' randomization to their death due to any cause. | three years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junling Li, MD | Contact | 13801178891 | drlijunling@vip.163.com | |
| Puyuan Xing, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Science | Recruiting | Beijing | China |
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The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.
| three years |
| 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 |
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