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

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ClinicalTrials.gov Identifier: NCT02283424
Recruitment Status : Unknown
Verified November 2014 by Yang Liu, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yang Liu, Chinese PLA General Hospital

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

Condition or disease Intervention/treatment Phase
Neoplasms, Therapy-Associated Drug: Icotinib Drug: chemotherapy (Carboplatin and Docetaxel) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: chemotherapy
Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks
Drug: Icotinib
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
Other Name: Conmana

Drug: chemotherapy (Carboplatin and Docetaxel)
as control group,compared with Icotinib
Other Name: Carboplatin and Docetaxel

Experimental: Icotinib
Icotinib, 125mg,3/D,2years
Drug: Icotinib
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
Other Name: Conmana

Drug: chemotherapy (Carboplatin and Docetaxel)
as control group,compared with Icotinib
Other Name: Carboplatin and Docetaxel




Primary Outcome Measures :
  1. Recurrence-free Survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283424


Locations
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China
PLA General Hospital
BeiJing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Yang Liu, doctor PLA General Hospital

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Responsible Party: Yang Liu, M.D., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02283424     History of Changes
Other Study ID Numbers: PLATS1401
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Neoplasms, Second Primary
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action