The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.
Age ≤ 75 years with histologically proven NSCLC
No severe major organ dysfunction
WHO performance status of 0 or 1
No prior cancer chemotherapy
Age ≥ 76
Severe major organ dysfunction
WHO performance status of >1
Prior cancer chemotherapy
Parallel
Cisplatin
DrugProcedure: Preoperative chemotherapy using Cisplatin (60mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Carboplatin
DrugProcedure: Preoperative chemotherapy using Carboplatin (400mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Docetaxel
DrugProcedure: Preoperative chemotherapy using Docetaxel (120mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Gemcitabine/Carboplatin
DrugProcedure: Preoperative chemotherapy using Gemcitabine (200mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Gemcitabine/Cisplatin
DrugProcedure: Preoperative chemotherapy using Gemcitabine (200mg) and Cisplatin (60mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Docetaxel/Oxaliplatin
DrugProcedure: Preoperative chemotherapy using Docetaxel (120mg) and Oxaliplatin (200mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Docetaxel/Carboplatin
DrugProcedure: Preoperative chemotherapy using Docetaxel (120mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
Placebo
DrugRegular placebo in replacement of agent-specific chemotherapy was supplied to these patients.
8
Treatment groupsSee each treatment group below.
5 years disease-free survival
The disease-associated survival status during the 5 years post treatment will be measured. Note the information in the Outcome Measure is only study hypothesis.
5 years overall survival
The overall survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
5 years metastasis-free survival
The metastasis-associated survival status during the 5 years post treatment will be measured. Information in the Outcome Measure is only study hypothesis.
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai 10th People's Hospital
Collaborator
Jilin University
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
