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Sponsored by: |
Clinical Research Center for Solid Tumor, Korea |
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Information provided by: | Clinical Research Center for Solid Tumor, Korea |
ClinicalTrials.gov Identifier: | NCT00349492 |
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Drug: Etoposide/Cisplatin, Irinotecan/Cisplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dae Seog Heo, MD, PhD | +82-2-2072-2857 | heo1013@snu.ac.kr |
Contact: Mi Rang Shim, RN | +82-2-2072-1742 | li_ming@hanmail.net |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Principal Investigator: Dae Seog Heo, M.D | |
Kangnam St.Mary's Hospital | Not yet recruiting |
Seoul, Korea, Republic of, 137-040 | |
Principal Investigator: Jin-Hyoung Kang, M.D. | |
Kangbuk Samsung Hospital | Not yet recruiting |
Seoul, Korea, Republic of, 110-746 | |
Principal Investigator: Seung Sei Lee, M.D. | |
Gyeongsang National University Hospital | Not yet recruiting |
Jinju, Korea, Republic of, 660-702 | |
Principal Investigator: Hun-Gu Kim, M.D | |
Daegu Catholic University Hospital | Not yet recruiting |
Daegu, Korea, Republic of, 705-718 | |
Principal Investigator: Sung Hwa Bae, M.D. | |
Seoul Municipal Boramae Hospital | Not yet recruiting |
Seoul, Korea, Republic of, 156-707 | |
Principal Investigator: Byung-Su Kim, M.D. | |
Seoul Veterans Hospital | Recruiting |
Seoul, Korea, Republic of, 134-791 | |
Principal Investigator: Bong-Seog Kim, M.D. | |
Chung-Ang University Medical Center | Not yet recruiting |
Seoul, Korea, Republic of, 151-756 | |
Principal Investigator: Joung Soon Jang, M.D. | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Principal Investigator: Sang-We Kim, M.D. | |
St.Vincent Hospital | Recruiting |
Suwon, Korea, Republic of, 422-723 | |
Principal Investigator: Hoon-Kyo Kim, M.D. | |
Yonsei Cancer Center | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Principal Investigator: Joo-Hang Kim, M.D. | |
Soonchunhyang University Bucheon Hospital | Not yet recruiting |
Bucheon-si, Korea, Republic of, 420-767 | |
Principal Investigator: Dae-Sik Hong, M.D. | |
Yeungnam University Hospital | Recruiting |
Daegu, Korea, Republic of, 705-717 | |
Principal Investigator: Kyung Hee Lee, M.D. | |
Seoul National University Bundang Hospital | Not yet recruiting |
Seongnam-Si, Korea, Republic of, 463-707 | |
Principal Investigator: Jong-Seok Lee, M.D. |
Principal Investigator: | Dae Seog Heo, MD, PhD | Seoul National University Hospital |
Study ID Numbers: | CRCST-L-0001 |
Study First Received: | July 5, 2006 |
Last Updated: | July 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00349492 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Small Cell Lung Cancer Extensive Disease Chemotherapy Randomisation |
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 |