Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02088515|
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Drug: Nedaplatin Drug: Cisplatin Drug: Docetaxel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nedaplatin (Jiebaishu®) and Docetaxel in Comparison With Cisplatin and Docetaxel Regimen for the First Line Treatment of Advanced Squamous Cell Carcinoma of Lung(IIIB/IV): Randomized, Controlled, Multicentre Study|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||February 2017|
Experimental: experimental group
experimental group: Nedaplatin(（80 mg/m2, i.v Day1）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total.
Active Comparator: comparative group
comparative group:Cisplatin (（75 mg/m2, i.v Day1 or 25 mg/m2 Day1-3）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total
- progress free survival [ Time Frame: 9 months ]after being enrolled, the subjects will be subject to 4 cycles chemotherapy (each cycle: 21 days). if complete response/partial response/stable desease is confirmed, the subjects will be followed up till to the sixth months.
- Objective Response Rate [ Time Frame: 3 months ]the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject.
- Adverse Events [ Time Frame: 10 months ]Adverse Events will be recorded and monitored till to normal or basal level achieved.
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): NCT02088515
|Hunan Xiangya Hospital|
|Changsha, Hunan, China|
|Nanjing Military General Hospital|
|Nanjing, Jiangsu, China|
|Shanghai Chest hospital|
|Shanghai, Shanghai, China, 200000|
|Xian, Shanxi, China|