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

Neoplasms, Therapy-Associated Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02283424
• Other study ID #: PLATS1401
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 30, 2014
• Last updated: November 4, 2014
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2014
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Neoplasms, Second Primary
• Neoplasms, Therapy-Associated

Intervention

Drug:
• Icotinib
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
• chemotherapy (Carboplatin and Docetaxel)
as control group,compared with Icotinib

Locations

Country	Name	City	State
China	PLA General Hospital	BeiJing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival		6 months	No
Secondary	Overall survival		6 months	No