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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
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.
Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options. In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
China-Japan Union Hospital, Jilin University
Changchun, Jilin, China
Shanghai 10th People's Hospital
Shanghai, China
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Shanghai, China
Start Date
January 1, 2008
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2027
Last Updated
April 17, 2024
500
ESTIMATED participants
Cisplatin
DRUG
Carboplatin
DRUG
Docetaxel
DRUG
Gemcitabine/Carboplatin
DRUG
Gemcitabine/Cisplatin
DRUG
Docetaxel/Oxaliplatin
DRUG
Docetaxel/Carboplatin
DRUG
Placebo
DRUG
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
NCT01958372
NCT01999881
Data Source & Attribution
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