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This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-year treatment with icotinib | Experimental | Patients will receive 1-year treatment with icotinib after operation. |
|
| 2-year treatment with icotinib | Experimental | Patients will receive 2-year treatment with icotinib after operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-year treatment with icotinib | Drug | Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Yang, MD | Contact | 86-10-88196568 | zlyangyue@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yue Yang, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer hospital | Recruiting | Beijing | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23621919 | Background | Lv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96. | |
| 37348348 |
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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 |
|---|---|
| D013812 | Therapeutics |
| C531470 | icotinib |
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|
| 2-year treatment with icotinib | Drug | Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years. |
|
|
| Lv C, Wang R, Li S, Yan S, Wang Y, Chen J, Wang L, Liu Y, Guo Z, Wang J, Pei Y, Yu L, Wu N, Lu F, Gao F, Chen J, Liu Y, Wang X, Li S, Han B, Zhang L, Ma Y, Ding L, Wang Y, Yuan X, Yang Y. Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study). ESMO Open. 2023 Aug;8(4):101565. doi: 10.1016/j.esmoop.2023.101565. Epub 2023 Jun 20. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |