Clinical trial NCT04752930: ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Peritoneal Metastases
Keywords: ctDNA
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Peritoneal Metastasis Free Survival (PMFS)
timeFrame: Through study completion, up to 3 years
Secondary outcomes:
measure: Detection Rate (DR)
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: Positive Percent Agreement (PPA)
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: Negative Percent Agreement (NPA)
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: The time of peritoneal metastasis diagnosed after radical surgery
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: Peritoneal Cancer Index (PCI) Score
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: Completeness of Cytoreduction (CC) Score
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: The ctDNA clearance rate before and after CRS+HIPEC treatment
timeFrame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
measure: The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer
timeFrame: Through study completion, up to 3 years
measure: The Overall Survival (OS) at 3 years after radical resection of colorectal cancer
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
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