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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Neoplasms, Therapy-Associated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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chemotherapy

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

Group Type ACTIVE_COMPARATOR

Icotinib

Intervention Type DRUG

compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery

chemotherapy (Carboplatin and Docetaxel)

Intervention Type DRUG

as control group,compared with Icotinib

Icotinib

Icotinib, 125mg,3/D,2years

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery

chemotherapy (Carboplatin and Docetaxel)

Intervention Type DRUG

as control group,compared with Icotinib

Interventions

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Icotinib

compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery

Intervention Type DRUG

chemotherapy (Carboplatin and Docetaxel)

as control group,compared with Icotinib

Intervention Type DRUG

Other Intervention Names

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Conmana Carboplatin and Docetaxel

Eligibility Criteria

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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