Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer

Phase 2

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.

Recruitment & Eligibility

Inclusion Criteria

Patients with histologically or cytologically proven small cell lung cancer
Patients receiving chemotherapy for the first time
Patients with no indication for radical radiotherapy or surgical resection
Patients diagnosed as ED* by full staging [chest X ray, chest C, brain CT or MRI, abdominal CT or abdominal ultrasonography, whole body bone scintigraphy (may be replaced by PET/CT)]
- ED: Patient with distant metastasis including contralateral hilar lymph node metastasis, but ipsilateral pleural effusion without distant metastasis is excluded.
Patients with lesions measurable or evaluable by the RECIST criteria
Patients aged from 20 years to below 75 years
Patients with preserved organ functions as indicated by the following test values (data obtained within 14 days prior to registration) Hemoglobin: ≥9.0 g/dL White blood cell count: ≥4,000/mm3, ≤12,000 /mm3 Neutrophil count: ≥ 2,000/mm3 Platelet count: ≥100,000 /mm3 GOT, GPT: below 2.5 times the upper limit of normal range for individual facility Total bilirubin: ≤1.5 mg/dL Serum creatinine: below the lower limit of normal range for individual facility Creatinine clearance: ≥ 60mL/min Arterial oxygen tension （PaO2）: ≥60 torr (resting)
Performance status (PS): 0-1
Absence of serious concurrent cardiac or pulmonary disease
Patients expected to survive for at least 3 months
Patients from whom written informed consent can be obtained

Exclusion Criteria

Patients with serious infection and other serious complications (including gastrointestinal bleeding and diarrhea)
Patients with pleural effusion, ascites, or pericardial effusion that requires treatments including puncture drainage and intracavity administration
Patients showing definite interstitial pneumonitis or pulmonary fibrosis on plain chest radiograph
Patients manifesting central nervous system symptoms due to brain metastasis at registration
Patients with active multiple cancers
Patients who had undergone bone marrow transplantation
Patients who had undergone peripheral blood stem cell transplantation
Patients with a history of definite drug allergy
Pregnant and nursing patients, patients who may be pregnant or who intend to become pregnant
Male patients with reproductive capacity who have no intention of contraception during the clinical trial
Patients with poorly controlled diabetes
Patients who had been administered Krestin in the past
Others: patients who are judged by the investigator or subinvestigator to be unsuitable as subject

Arm && Interventions

Group	Intervention	Description
1	Krestin	Irinotecan hydrochloride + Cisplatin + Krestin Therapy
1	Cisplatin	Irinotecan hydrochloride + Cisplatin + Krestin Therapy
1	Irinotecan hydrochloride	Irinotecan hydrochloride + Cisplatin + Krestin Therapy

Primary Outcome Measures

Name	Time	Method
Overall survival rate	one year

Secondary Outcome Measures

Name	Time	Method
Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity	one year

Locations (15): Osaka Medikal College Hospital
🇯🇵
Takatsuki, Osaka, Japan
Kanazawa University Hospital
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Kanazawa, Ishikawa, Japan
Toyama University Hospital
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Toyama, Japan
Hokkaido University Hospital
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Sapporo, Hokkaido, Japan
Kinkidaigakuigakubu Nara Hospital
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Ikoma, Nara, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
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Habikino, Osaka, Japan
Toho University Sakura Medical Center
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Sakura, Chiba, Japan
Kanazawa Medical University Hospital
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Uchinada, Ishikawa, Japan
NHO Kinki-chuo Chest Medical Center
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Sakai, Osaka, Japan
Kurashiki Central Hospital
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Kurashiki, Okayama, Japan
Kinkidaigakuigakubu Sakai Hospital
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Sakai, Osaka, Japan
Hiroshima City Hospital
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Hiroshima, Japan
Tokyo Medical University Hospital
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Tokyo, Japan
Osaka City General Hospital
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Osaka, Japan
Toyama Red Cross Hospital
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Toyama, Japan