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

Primary Purpose

Neoplasms, Therapy-Associated

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Icotinib
chemotherapy (Carboplatin and Docetaxel)
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Therapy-Associated

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

chemotherapy

Icotinib

Arm Description

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

Icotinib, 125mg,3/D,2years

Outcomes

Primary Outcome Measures

Recurrence-free Survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
October 30, 2014
Last Updated
November 4, 2014
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02283424
Brief Title
Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Therapy-Associated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib, 125mg,3/D,2years
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Conmana
Intervention Description
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
Intervention Type
Drug
Intervention Name(s)
chemotherapy (Carboplatin and Docetaxel)
Other Intervention Name(s)
Carboplatin and Docetaxel
Intervention Description
as control group,compared with Icotinib
Primary Outcome Measure Information:
Title
Recurrence-free Survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Liu, doctor
Organizational Affiliation
PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PLA General Hospital
City
BeiJing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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