jRCTs032220652进行中（未招募）不适用
A clinical study to evaluate the decision-making process for adjuvant chemotherapy for resected colorectal cancer using Guardant Reveal
未提供0 个研究点目标入组 100 人开始时间: 2023年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 主要终点
- Percentage of patients with recommended treatment change
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Health Services Research
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically confirmed adenocarcinoma of the colon or rectum, pathologically confirmed after radical.
- •Patients must be at least 20 years of age at the date of enrollment.
- •ECOG Performance status (PS) is 0 or
- •The latest laboratory values within 28 days prior to enrollment meet all of the following (laboratory tests on the same day of the week 4 weeks prior to the enrollment date are acceptable)
- •1.Neutrophil count >= 1500/mm3
- •2.Hemoglobin >= 9.0 g/dL
- •3.Platelet count >=10000/mm3
- •4.Total bilirubin <=1.5 mg/dL
- •5.AST(GOT) <=100 IU/L
- •6.ALT (GPT) <=100 IU/L
- •7.Creatinine <=1.5 mg/dL
- •Adjuvant therapy can be started within 8 weeks after surgery.
- •Written consent to participate in the study has been obtained from the patient.
排除标准
- •Previous history of malignancy (with a recurrence-free period of at least 5 years, and endoscopically curatively resected intramucosal carcinoma (gastric, colorectal, or esophageal cancer) or curatively resected cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin are acceptable).
- •Active overlapping cancers [synchronous overlapping cancers and heterochronic overlapping cancers with a disease-free period of 2 years or less.
- •However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treat ment are not included in active overlapping cancers.] 2) The patient has an active overlapping carcinoma in situ (carcinoma in situ).
- •Prior chemotherapy, including treatment for other types of cancer (excluding hormonetherapy).
- •Patient has serious (requiring hospitalization) complications (intestinal paralysis, intestinal obstruction, pulmonary fibrosis, diabetes mellitus that is difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, psychiatric disease, cerebrovascular disease, etc.)
- •Other conditions that make the patient unsuitable for participation in the clinical trial as determined by the physician in charge.
结局指标
主要结局
Percentage of patients with recommended treatment change
This is defined as the percentage of patients whose recommended treatment changed before and after the initial Guardant Reveal test in the FAS. A change in recommended therapy is defined as at least one of the following: - Addition or deletion of oxaliplatin - Change in the use of postoperative adjuvant therapy - Change in duration of adjuvant therapy.
次要结局
未报告次要终点
研究者
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