臨床研究等提出・公開システム

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

GR study (GR study)

Shinozaki Eiji

Cancer Institute Hospital of Japanese Foundation for Cancer Research

3-8-31 Ariake, Koto-ku, Tokyo, Japan

eiji.shinozaki@jfcr.or.jp

Fukuoka Shota

Cancer Institute Hospital of Japanese Foundation for Cancer Research

3-8-31 Ariake, Koto-ku, Tokyo, Japan

+81-3-3520-0111

shota.fukuoka@jfcr.or.jp

Not Recruiting

Feb. 22, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

health services research

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
7.Creatinine <=1.5 mg/dL
5) Adjuvant therapy can be started within 8 weeks after surgery.
6) Written consent to participate in the study has been obtained from the patient.

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.

Both

Colorectal cancer

Share the result of Guardant Reveal test with the patient

Colorectal cancer

ctDNA

This is defined as the percentage of patients whose recommended treatment changed before and after the initial Guardant Reveal test in the FAS. Thisis defined as the percentage of patients for whom the recommended treatment was changed before or after the initial Guardant Reveal test.

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.

1.Level of physician confidence in recommended treatment
2. Decisional Conflict Scale
3. Percentage of patients for whom the recommended treatment after the second Guardant Reveal was changed from the treatment that had been expected before the initial test.
4. Percentage of patients whose recommended treatment after the second test changed from the recommended treatment after the first test.
5. Disease free survival
6. Overall survival
7. Frequency of adverse events

+81-3-3570-0703

Feb. 16, 2023

No

None