A Multi-Center Randomized Trial of Cisplatin, Carboplatin, Oxaliplatin, Docetaxel, and Gemcitabine Plus Surgery for Relapsed and Refractory Non-Small Cell Lung Cancer

What this Trial Is About

This research investigates the effectiveness of commonly used chemotherapy drugs, including cisplatin, carboplatin, oxaliplatin, docetaxel, and gemcitabine, alone or in combination followed by surgery, for patients with relapsed and refractory non-small cell lung cancer (NSCLC). NSCLC is the most prevalent type of lung cancer, known for its high mortality and limited treatment options. The study is a Phase I, open-label, multicenter clinical trial aiming to evaluate treatment outcomes such as five-year disease-free survival and overall survival. Participants receive various chemotherapy regimens before and after surgery. Treatments include single agents like carboplatin or docetaxel, combinations like gemcitabine/cisplatin or docetaxel/oxaliplatin, and a placebo group for comparison. Chemotherapy is administered intravenously once a week for four cycles, starting 30 days before surgery, with surgery following two days after the last dose. After surgery, the same chemotherapy regimen is given for three cycles, each spaced 30 days apart. During the study, participants undergo assessments including tumor evaluations and monitoring of survival outcomes over five years. The research also examines the extent of tumor stroma damage caused by chemotherapy and its impact on disease progression. The total participation duration includes treatment cycles before and after surgery and long-term follow-up to assess survival and metastasis-free status.

A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer