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NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations. (NEGOTIATE)

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ClinicalTrials.gov Identifier: NCT02347839
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Brief Summary:
The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Gefitinib-surgery-gefitinib Phase 2

Detailed Description:
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable EGFR mutant stage III NSCLC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Trial of Neoadjuvant Gefitinib Followed by Surgery, Followed by Adjuvant Gefitinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations.
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Intervention group
Gefitinib-surgery-gefitinib. Induction gefitinib therapy was given for 8 weeks. Patients' resectability was assessed after 8-week gefitinib. Adjuvant gefitinib was given within 3-6 weeks after surgery until progression or unacceptable toxic effects.
Procedure: Gefitinib-surgery-gefitinib
neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib
Other Name: neooadjuvant gefitinib followed by surgery and gefitinib




Primary Outcome Measures :
  1. Resectability rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of participants with perioperative complications [ Time Frame: 1 year ]
  2. Event-free survival [ Time Frame: 2 years after the last patient is randomized ]
    Event-free survival was assessed from randomization to disease recurrence/progression or death from any cause.

  3. Overall survival [ Time Frame: 2 years after the last patient is randomized ]
    Overall survival was assessed from randomization to death from any cause.



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:

  • Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21
  • Written informed consent provided
  • Aged 18-75 years
  • Able to comply with the required protocol and follow-up procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Had a life expectancy of 12 weeks or more
  • Adequate hematological function, liver function and renal function
  • Female participants should not be pregnant or breast-feeding

Exclusion Criteria:

  • Known severe hypersensitivity to gefitinib or any of the excipients of this product
  • Inability to comply with protocol or study procedures
  • Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)
  • Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder
  • Interstitial pneumonia
  • Eye inflammation not fully controlled or conditions predisposing the subject to this
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
  • Known human immunodeficiency virus (HIV) infection
  • Pregnancy or breast-feeding women
  • History of neurologic or psychiatric disorders
  • Ingredients mixed with small cell lung cancer patients

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): NCT02347839


Contacts
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Contact: Si-Yu Wang, MD +86 20 87343439 wsysums@163.net

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Si-Yu Wang, Doctor    +86 20 87343439    wsysums@163.net   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Si-Yu Wang Guangdong Province Association Study of Thoracic Oncology

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Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02347839    
Other Study ID Numbers: GASTO1004
wsy005 ( Other Identifier: Guangdong Province Association Study of Thoracic Oncology )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action