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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
Toho University Sakura Medical Center
Sakura, Chiba, Japan
RECRUITINGHiroshima City Hospital
Hiroshima, Hiroshima, Japan
Overall survival rate
Time frame: one year
Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity
Time frame: one year
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Hokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGKanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
RECRUITINGKanazawa Medical University Hospital
Mukai-awagasaki, Ishikawa-ken, Japan
RECRUITINGKinkidaigakuigakubu Nara Hospital
Ikoma, Nara, Japan
RECRUITINGKurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
RECRUITINGOsaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, Japan
RECRUITINGOsaka City General Hospital
Osaka, Osaka, Japan
RECRUITINGKinkidaigakuigakubu Sakai Hospital
Sakai, Osaka, Japan
NOT_YET_RECRUITING...and 5 more locations