Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation
Phase 4
- Conditions
- Neoplasms, Therapy-Associated
- Interventions
- Drug: chemotherapy (Carboplatin and Docetaxel)
- Registration Number
- NCT02283424
- Lead Sponsor
- Chinese PLA General Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Icotinib chemotherapy (Carboplatin and Docetaxel) Icotinib, 125mg,3/D,2years chemotherapy chemotherapy (Carboplatin and Docetaxel) Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks Icotinib Icotinib Icotinib, 125mg,3/D,2years chemotherapy Icotinib Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
- Primary Outcome Measures
Name Time Method Recurrence-free Survival 6 months
- Secondary Outcome Measures
Name Time Method Overall survival 6 months
Trial Locations
- Locations (1)
PLA General Hospital
🇨🇳BeiJing, China
PLA General Hospital🇨🇳BeiJing, China