A clinical study to evaluate the decision-making process for adjuvant chemotherapy for resected colorectal cancer using Guardant Reveal

Shinozaki Eiji0 sites100 target enrollmentFebruary 22, 2023

Overview

No summary available.

Registry

who.int

Start Date

February 22, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Shinozaki Eiji

•1\) Histologically confirmed adenocarcinoma of the colon or rectum, pathologically confirmed after radical.
•2\)Patients must be at least 20 years of age at the date of enrollment.
•3\) ECOG Performance status (PS) is 0 or 1\.
•4\) 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

•1\) 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).
•2\) 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).
•3\) Prior chemotherapy, including treatment for other types of cancer (excluding hormonetherapy).
•4\) 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.)
•5\) Other conditions that make the patient unsuitable for participation in the clinical trial as determined by the physician in charge.