NCT00209651Unknown2 期
Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- objective tumor response
研究概览
简要总结
To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.
详细描述
A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of colorectal adenocarcinoma.
- •Measurable or assessable lesions.
- •Age: 18 ~ 75 years.
- •Performance Status (ECOG): 0 ~
- •No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
- •No history of treatment with CPT-11 or S-
- •No history of radiotherapy to the abdomen.
- •Oral intake of S-1 is possible.
- •Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm
- •Hb 10.0 g/dl. Platelet count 100,000/mm
- •GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
- •Predicted survival for >3 months.
- •Able to give written informed consent
排除标准
- •Severe pleural effusion or ascites.
- •Metastasis to the central nervous system (CNS).
- •Active gastrointestinal bleeding.
- •Active infection.
- •Diarrhea (watery stools).
- •Uncontrolled ischemic heart disease.
- •Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- •Active multiple cancer.
- •Severe mental disorder.
- •Pregnancy, possible pregnancy, or breast-feeding.
- •Flucytosine treatment
- •Gilbert's syndrome (4).
- •Judged to be ineligible for this protocol by the attending physician.
研究组 & 干预措施
1
Experimental
Irinotecan and S-1
干预措施: Campto, Topotesin (Drug)
1
Experimental
Irinotecan and S-1
干预措施: TS-1 (Drug)
结局指标
主要结局
objective tumor response
时间窗: 1-year
次要结局
- Response duration, time to progression, overall survival, and safety will also be assessed.(2-years)
研究者
研究点 (1)
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