Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Neoplasms, Therapy-Associated

Treatments: Drug: chemotherapy (Carboplatin and Docetaxel); Drug: Icotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02283424

PLATS1401

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

chemotherapy

Active Comparator group

Description:

Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks

Treatment:

Drug: Icotinib

Drug: chemotherapy (Carboplatin and Docetaxel)

Icotinib

Experimental group

Description:

Icotinib, 125mg,3/D,2years

Treatment:

Drug: Icotinib

Drug: chemotherapy (Carboplatin and Docetaxel)