A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer
A Multi-Center and Randomized Control Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery as Treatment for Relapsed and Refractory Non-Small Cell Lung Cancer
Shanghai Jiao Tong University School of Medicine
500 participants
Jan 1, 2008
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Age ≤ 75 years with histologically proven NSCLC
- No severe major organ dysfunction
- WHO performance status of 0 or 1
- No prior cancer chemotherapy
- A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
Exclusion Criteria5
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of \>1
- Prior cancer chemotherapy
- Stage IV
Interventions
Procedure: 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.
Procedure: 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.
Procedure: 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.
Procedure: 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.
Procedure: 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.
Procedure: 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.
Procedure: 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.
Regular placebo in replacement of agent-specific chemotherapy was supplied to these patients.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT02889666