JPRN-jRCTs031210660招募中2 期
A prospective study on the safety and efficacy of preoperative UFT/UZEL+CPT-11+irradiation combined with FOLFOX or CAPOX for locally advanced lower rectal cancer
Ishihara Soichiro0 个研究点目标入组 30 人开始时间: 2022年3月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Those who meet all of the following selection criteria are targeted.
- •1) The below rectum tumor or even if the above rectal tumor reaches the below rectum
- •2) Cases confirmed to be adenocarcinoma histologically
- •3) Cases judged to fall under any of the following by preoperative diagnosis using MRI or CT
- •(1) Cases of infiltration into surrounding organs (T4b, anyN)
- •(2) Cases with suspected advanced lymph node metastasis such as lateral lymph node metastasis
- •(3) Cases diagnosed with suspicion of Extramural Venous Invasion (EMVI)
- •4) Cases without distant organ metastasis
- •5) Cases of age 20 to 80 years (at the time of obtaining consent)
- •6) Cases in which radiation therapy, chemotherapy, or hormone therapy is not performed as pretreatment
- •7) Cases in which food can be ingested and drugs can be orally administered
- •8) Cases in which the functions of major organs (bone marrow, heart, lungs, liver, kidneys, etc.) are sufficiently maintained: The doctor makes a judgment based on the following values.
- •a. White blood cell count: 4,000 / mm3 and more, and 12,000 / mm3 and less
- •b. Number of neutrophils: 2,000 / mm3 or more
- •c. Platelet count: 100,000 / mm3 or more
- •d. Hemoglobin: 9.0 g / dl or higher
- •e. Total bilirubin: 1.5 mg / dl or less
- •f. AST (GOT) / ALT (GPT): 100 IU / L and less
- •g. Serum creatinine clearance: 60.0 mL / min and more *
- •* If the creatinine clearance by 24-hour urine collection is actually measured, use that value.
- •If there is no measured value, calculate the estimated value using the following Cockcroft-Gault estimation formula
- •Male: creatinine clearance = body weight x (140-age) / (72 x serum creatinine level)
- •Female: creatinine clearance = 0.85 x {weight x (140-age) / (72 x serum creatinine level)}
- •9) Cases with no abnormal findings on the electrocardiogram (abnormalities without clinical problems are acceptable)
- •10) Cases with a general performance status (P.S.) of 0 to 1
- •11) Cases without sensory neuropathy
- •12) Cases in which the research subject has given written consent to participate in the study
排除标准
- •Those who meet any of the following exclusion criteria will be excluded from the target.
- •1) Cases with a history of drug hypersensitivity
- •2) Cases where UFT / UZEL is contraindicated
- •3) Cases where administration of CPT-11 is contraindicated
- •4) Cases of UGT1A1 *6/*6, UGT1A1 *28/*28 and heterozygotes (UGT1A1*6/*28)
- •5) Cases where 5-FU administration is contraindicated
- •6) Cases where administration of LV is contraindicated
- •7) Cases where L-OHP administration is contraindicated
- •8) Cases where administration of Capecitabine is contraindicated
- •9) Cases receiving flucytosine, phenytoin, and potassium warfarin
- •10) Cases with active infectious diseases (fever 38.0 degree or higher)
- •11) Cases with serious complications (intestinal palsy, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poor control or severe diabetes, heart failure, renal failure, liver failure, autoimmune disease, etc.)
- •12) Cases with diarrhea (more than 4 times a day or watery stool)
- •13) Patients with clinical brain metastases and cases with a history of brain metastases
- •14) Cases with simultaneous double cancer or metachronous double cancer with a disease-free period of 5 years or less
- •15) Pregnant or lactating women, or with the potential (will) to become pregnant
- •16) Men who wish to have children
- •17) Other cases that the doctor in charge deems inappropriate as a target
研究者
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