Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma
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|ClinicalTrials.gov Identifier: NCT02428764|
Recruitment Status : Unknown
Verified October 2017 by Si-Yu Wang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : April 29, 2015
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Nimotuzumab Drug: Gemcitabine Drug: Carboplatin Procedure: Surgery||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 Induction Nimotuzumab Plus Gemcitabine and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Squamous Cell Lung Carcinoma|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2020|
Experimental: Intervention group
Patients were assigned to receive neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery.
Nimotuzumab was given 200 mg i.v. injection over 30 min on days 1 and 8
Gemcitabine was given 1000 mg/m2 i.v. injection on days1 and 8.
Other Name: Gemzar
carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1.
Other Name: CBP
Patients' resectability was assessed by a medical team, including thoracic surgeons, medical oncologists, and radiologists.
- 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 enrolled ]Event-free survival was assessed from diagnosis to disease recurrence/metastasis/progression or death as a result of any cause.
- Overall survival [ Time Frame: 2 years after the last patient is enrolled ]Overall survival was assessed from diagnosis to death as a result of 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): NCT02428764
|Contact: Si-Yu Wang, MD||+86 20 email@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Si-Yu Wang, Doctor +86 20 87343439 firstname.lastname@example.org|
|Principal Investigator:||Si-Yu Wang, MD||Guangdong Province Association Study of Thoracic Oncology|