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

Study Overview
=================
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.

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

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan hydrochloride
* Drug: Cisplatin
* Drug: Krestin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Irinotecan hydrochloride + Cisplatin + Krestin Therapy | Drug: Irinotecan hydrochloride<br>* 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.<br>* Other names: Irinotecan hydrochloride: CPT-11;Drug: Cisplatin<br>* 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.<br>* Other names: Cisplatin: CDDP;Drug: Krestin<br>* Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.<br>* Other names: Krestin: PSK;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ED-SCLC, small cell lung cancer, CPT-11, irinotecan hydrochloride, CDDP, cisplatin, PSK, Krestin