Spots Global Cancer Trial Database for Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
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Trial Identification
Brief Title: Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
Official Title: Feasibility Study for Multicenter Randomized Controlled Phase III Clinical Trial of Cisplatin + Irinotecan Therapy and Cisplatin + Irinotecan + Krestin Therapy for Extensive-Stage Disease (ED) Small Cell Lung Cancer
Study ID: NCT00546130
Conditions
Study Description
Brief Summary: The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation and comparing with historical control or community control is appropriate as the protocol and regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer.
Detailed Description: To examine whether the following protocol and regimen is appropriate for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer: set test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation, evaluate the efficacy and safety of treatment in a small number of cases, and compare with historical control or community control.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Toho University Sakura Medical Center, Sakura, Chiba, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kanazawa Medical University Hospital, Uchinada, Ishikawa, Japan
Kinkidaigakuigakubu Nara Hospital, Ikoma, Nara, Japan
Kurashiki Central Hospital, Kurashiki, Okayama, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Osaka, Japan
Kinkidaigakuigakubu Sakai Hospital, Sakai, Osaka, Japan
NHO Kinki-chuo Chest Medical Center, Sakai, Osaka, Japan
Osaka Medikal College Hospital, Takatsuki, Osaka, Japan
Hiroshima City Hospital, Hiroshima, , Japan
Osaka City General Hospital, Osaka, , Japan
Tokyo Medical University Hospital, Tokyo, , Japan
Toyama University Hospital, Toyama, , Japan
Toyama Red Cross Hospital, Toyama, , Japan
Contact Details
Name: Tatsuhiko Kashii, MD, PhD
Affiliation: Research Network for Chemotherapy of Lung Cancer
Role: STUDY_CHAIR
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