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
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 15
- 主要终点
- Overall survival rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
干预措施: Irinotecan hydrochloride (Drug)
1
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
干预措施: Cisplatin (Drug)
1
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
干预措施: Krestin (Drug)
结局指标
主要结局
Overall survival rate
时间窗: one year
次要结局
- Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity(one year)