Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Primary Outcome Measure:
Disease-free survival between Icotinib group and placebo group.
Secondary Outcome Measures:
Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | 125 mg three times daily (375 mg per day) by mouth |
|
| Placebo | Active Comparator | 1 tablet three times daily by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | 125 mg three times daily (375 mg per day) by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive. | 60 months |
| Lung cancer symptoms and health-related quality of life (HRQoL) differences |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Kai Shi, MD | Contact | 010-87788293 |
| Name | Affiliation | Role |
|---|---|---|
| Yuan-Kai Shi, MD | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32606956 | Derived | Liu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020 Jun 17;12:4633-4643. doi: 10.2147/CMAR.S240275. eCollection 2020. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C531470 | icotinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 1 tablet three times daily by mouth |
|
| 60 months |
| Number of participants with adverse events | 36 months |
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
|
| Beijing Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
|
| Cancer Hospital, Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100021 | China |
|
| China-japan friendship hospital in Beijing | Recruiting | Beijing | Beijing Municipality | 100029 | China |
|
| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| 304 Hospital of PLA | Recruiting | Beijing | Beijing Municipality | 100048 | China |
|
| Xuanwu Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100053 | China |
|
| People's Liberation Army General Hospital (301 Hospital) | Not yet recruiting | Beijing | Beijing Municipality | 100853 | China |
|
| Capital Medical University, Beijing Chest Hospital | Recruiting | Beijing | Beijing Municipality | 101149 | China |
|