Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country138 target enrollmentAugust 24, 2020

ConditionsColorectal Cancer Peritoneal Metastases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment: 138
Locations: 1
Primary Endpoint: Peritoneal Metastasis Free Survival (PMFS)
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.

Registry

clinicaltrials.gov

Start Date

August 24, 2020

End Date

August 24, 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be a man or woman of at 18-75;
•Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；
•Patients with primary colorectal cancer proven by pathology；
•Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);
•6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
•Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)；
•Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ;
•Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study.

Exclusion Criteria

•Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;
•ASA class Ⅳ to Ⅴ;
•Patients who have other existence of distant metastasis outside the abdomen;
•Patients with serious mental illness;
•Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
•Patients who cannot be followed up as scheduled;
•Patients who participated in other clinical studies within 3 months prior to the trial;
•Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.

Outcomes

Primary Outcomes

Peritoneal Metastasis Free Survival (PMFS)

Time Frame: Through study completion, up to 3 years

The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.

Secondary Outcomes

The ctDNA clearance rate before and after CRS+HIPEC treatment(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer(Through study completion, up to 3 years)
The Overall Survival (OS) at 3 years after radical resection of colorectal cancer(Through study completion, up to 3 years)
Positive Percent Agreement (PPA)(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
Negative Percent Agreement (NPA)(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
Peritoneal Cancer Index (PCI) Score(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
Detection Rate (DR)(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
The time of peritoneal metastasis diagnosed after radical surgery(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)
Completeness of Cytoreduction (CC) Score(Interim analyses: After 69 patients have been enrolled, up to 1.5 years)