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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: | NCT00144989 |
To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.
Condition | Intervention | Phase |
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Small-Cell-Lung Cancer |
Drug: Etoposide and cisplatin after chemoradiotherapy Drug: Irinotecan and cisplatin after chemoradiotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF |
Estimated Enrollment: | 270 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | September 2011 |
The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Yutaka Nishiwaki, MD | National Cancer Center Hospital East |
Study ID Numbers: | JCOG0202-MF, C000000095 |
Study First Received: | September 1, 2005 |
Last Updated: | March 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00144989 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Small-cell lung cancer Limited-Stage Small-Cell Lung Cancer Combined modality therapy chemotherapy |
radiotherapy Irinotecan Cisplatin |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Etoposide Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |