Overview

This trial is active, not recruiting.

Condition neoplasms, therapy-associated
Treatments icotinib, chemotherapy (carboplatin and docetaxel)
Phase phase 4
Target EGFR
Sponsor Chinese PLA General Hospital
Start date October 2014
End date October 2017
Trial size 10 participants
Trial identifier NCT02283424, PLATS1401

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
icotinib Conmana
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
chemotherapy (carboplatin and docetaxel) Carboplatin and Docetaxel
as control group,compared with Icotinib
(Experimental)
Icotinib, 125mg,3/D,2years
icotinib Conmana
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
chemotherapy (carboplatin and docetaxel) Carboplatin and Docetaxel
as control group,compared with Icotinib

Primary Outcomes

Measure
Recurrence-free Survival
time frame: 6 months

Secondary Outcomes

Measure
Overall survival
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.