Clinical trial of personalized therapy based on genetic alteration for patients with resectable colorectal oligometastases

Multi-center clinical trial for personalized perioperative chemotherapy based on genetic alteration status for resectable oligometastases from colorectal cancer - PRECISION Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042490

Enrollment

400

Registered

2020-11-18

Start date

2021-03-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal oligometastases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Above 20 years of age 2. Written informed consent 3. Colorectal cancer origin 4. Resectable oligometastases 5. Initial surgery is planed. 6. R0/1 resection is possible. 7. ECOG PS 0/1 In G360 cohort, in which pre-treatment ctDNA is analyzed, below criteria are also added. 1. Pathologically-proven adnocarcinoma 2. No prior treatment for oligometastases 3. Written consent for blood test

Exclusion criteria

Exclusion criteria: 1. Concomittant unresectable advanced tumor 2. Prior surgery for oligometastases 3. Unresectable unless the tumor is shrinked by preoperative chemotherapy 4. Physician`s judgement for exclusion In G360 cohort, below criteria are also added. 1. Concomittant tumor that is disease-free within 5 years 2. Pathological diagnosis other than adenocarcinoma 3. Any prior treatment for oligometastases

Design outcomes

Primary

Measure	Time frame
Proportion of BRAF V600E mutation and pre-treatment ctDNA detection in patients with resectable colorectal oligometastases	—

Secondary

Measure	Time frame
Survival outcomes depending on status of BRAF V600E mutation and pre-treatment ctDNA detection. Genetic alteration profiles according to ctDNA analysis.	—

Countries

Japan

Contacts

Public ContactShin Kobayashi

National Cancer Center Hospital East, Japan Department of Hepatobiliary and Pancreatic Surgery

shkobaya@east.ncc.go.jp04-7133-1111

Outcome results