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Sponsors and Collaborators: |
Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare |
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Information provided by: | Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00190476 |
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Non-Small-Cell Lung Cancer |
Drug: Weekly docetaxel alone Drug: Weekly docetaxel + cisplatin combination |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial Comparing Docetaxel-Cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-Small-Cell Lung Cancer(JCOG0207) |
Estimated Enrollment: | 230 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | April 2007 |
The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination. Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Akira Yokoyama, MD, PhD | Department of Internal Medicine, Niigata Cancer Center Hospital |
Study ID Numbers: | JCOG0207, C000000146 |
Study First Received: | September 11, 2005 |
Last Updated: | May 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00190476 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Elderly advanced non-small-cell lung cancer cisplatin docetaxel |
weekly combination chemotherapy randomized trial |
Docetaxel Thoracic Neoplasms Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |