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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Gefitinib-surgery-gefitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib
Other Name: neooadjuvant gefitinib followed by surgery and gefitinib
- Resectability rate [ Time Frame: 3 months ]
- Number of participants with perioperative complications [ Time Frame: 1 year ]
- 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.
- Overall survival [ Time Frame: 2 years after the last patient is randomized ]Overall survival was assessed from randomization to death from any cause.
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
|Contact: Si-Yu Wang, MD||+86 20 firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Si-Yu Wang, Doctor +86 20 87343439 email@example.com|
|Principal Investigator:||Si-Yu Wang||Guangdong Province Association Study of Thoracic Oncology|