A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- 3-Year recurrence-free survival rate
研究概览
简要总结
To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.
详细描述
To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III (UICC Sixth version) colorectal cancer/histological curability A (Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability A (including laparoscopic surgery) (the curability is judged after surgery)
- •Patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (T4) or with histologically positive lymph node metastasis (N+) (to be judged after surgery)
- •Patients who is between 20 and 80 years old at the time of obtaining informed consent
- •Patients with performance status of 0 - 2
- •Patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
- •Patients without severe dysfunction of renal, hepatic, or bone marrow function
- •Patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
- •Patients who have given consent to participate in this clinical study by himself/herself or his/her family
排除标准
- •Patients in whom the bottom of tumor reaches the peritoneal reflection
- •Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E)
- •Patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
- •Women who are currently pregnant or wish to be pregnant during this clinical study
- •Patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator
研究组 & 干预措施
1
UFT+LV Group: The group treated with UFT and LV
干预措施: Tegafur-uracil (UFT) (Drug)
1
UFT+LV Group: The group treated with UFT and LV
干预措施: Calcium folinate (LV) (Drug)
2
UFT+PSK Group: The group treated with of UFT and PSK
干预措施: Tegafur-uracil (UFT) (Drug)
2
UFT+PSK Group: The group treated with of UFT and PSK
干预措施: Krestin (PSK) (Drug)
结局指标
主要结局
3-Year recurrence-free survival rate
时间窗: 3-years after surgery
次要结局
- 5-Year survival rate, incidence of adverse events, treatment compliance, QOL, type of metastasis/recurrence, and 3-year and 5-year recurrence-free survival rates and survival rates based on each parameter including colon/rectum, stage, and IAP.(5-years after surgery)
研究者
Masataka Ikeda, MD, PhD.
Associate Director of Surgery, Osaka National Hospital
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group