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
Who is this study for? Patients with relapsed and refractory non-small cell lung cancer
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
China-Japan Union Hospital, Jilin University
RECRUITING
Changchun
Shanghai 10th People's Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital, Tongji University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Yu Sun, Ph.D
sunyu@sibs.ac.cn
86-21-54923302
Backup
Weijun Ma, Ph.D
wjma@sibs.ac.cn
86-21-54923268
Time Frame
Start Date: 2008-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 500
Treatments
Experimental: Carboplatin
Carboplatin-based chemotherapy (Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Carboplatin was done for 3 cycles with 30 days after last surgery.
Experimental: Docetaxel
Docetaxel-based chemotherapy (Docetaxel 120mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Docetaxel was done for 3 cycles with 30 days after last surgery.
Experimental: Gemcitabine/Cisplatin
Gemcitabine/Cisplatin-based combinational chemotherapy (Gemcitabine 200mg + Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Experimental: Cisplatin
Cisplatin-based chemotherapy (Cisplatin 60mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy using Cisplatin was done for 3 cycles with 30 days after last surgery.
Experimental: Docetaxel/Oxaliplatin
Docetaxel/Oxaliplatin-based chemotherapy (Docetaxel 120mg + Oxaliplatin 200mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Experimental: Docetaxel/Carboplatin
Docetaxel/Carboplatin-based chemotherapy (Docetaxel 120mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Experimental: Gemcitabine/Carboplatin
Gemcitabine/Carboplatin-based chemotherapy (Gemcitabine 200mg + Carboplatin 400mg) was performed 30 days before surgery for patients who had previous surgery to remove the primary non-small cell lung carcinoma but suffered from the recurrent disease. The same chemotherapy was done for 3 cycles with 30 days after last surgery.
Placebo_comparator: Placebo
No Adjuvant chemotherapy using CCODG was done for patients who had previous surgery to remove the primary non-small cell lung carcinoma but subject to tumor relapse. Instead, placebo was supplied to these patients as a comparator Arm.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, Shanghai 10th People's Hospital, Jilin University, Shanghai Tongji Hospital, Tongji University School of Medicine
Leads: Shanghai Jiao Tong University School of Medicine