A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation
Overview
- Phase
- Phase 4
- Intervention
- Icotinib
- Conditions
- Neoplasms, Therapy-Associated
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Recurrence-free Survival
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation
Detailed Description
In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up
Investigators
Yang Liu
M.D.
Chinese PLA General Hospital
Eligibility Criteria
Inclusion Criteria
- •18-75 years old
- •Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
- •The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
Exclusion Criteria
- •Mismatch conditions above
- •Have used other anti-cancer therapy drug before the trial and may influence the outcome
Arms & Interventions
chemotherapy
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
Intervention: Icotinib
chemotherapy
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
Intervention: chemotherapy (Carboplatin and Docetaxel)
Icotinib
Icotinib, 125mg,3/D,2years
Intervention: Icotinib
Icotinib
Icotinib, 125mg,3/D,2years
Intervention: chemotherapy (Carboplatin and Docetaxel)
Outcomes
Primary Outcomes
Recurrence-free Survival
Time Frame: 6 months
Secondary Outcomes
- Overall survival(6 months)