ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
- Conditions
- Peritoneal MetastasesColorectal Cancer
- Interventions
- Diagnostic Test: ctDNA monitoringDiagnostic Test: Imageology
- Registration Number
- NCT04752930
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ctDNA monitoring ctDNA monitoring ctDNA monitoring will be performed at protocol-specified intervals and requirement Imageology (SOC) Imageology Imaging examination will be performed at protocol-specified intervals and requirement
- Primary Outcome Measures
Name Time Method Peritoneal Metastasis Free Survival (PMFS) Through study completion, up to 3 years The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.
- Secondary Outcome Measures
Name Time Method The ctDNA clearance rate before and after CRS+HIPEC treatment Interim analyses: After 69 patients have been enrolled, up to 1.5 years Will be compared in both arms.
The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer Through study completion, up to 3 years Whether the patient is still alive and free of disease or not.
Will be compared in both arms.The Overall Survival (OS) at 3 years after radical resection of colorectal cancer Through study completion, up to 3 years Whether the patient is still alive or not.
Will be compared in both arms.Positive Percent Agreement (PPA) Interim analyses: After 69 patients have been enrolled, up to 1.5 years PPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.
PPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
PPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
Will be compared in both arms.Negative Percent Agreement (NPA) Interim analyses: After 69 patients have been enrolled, up to 1.5 years NPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.
NPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
NPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
Will be compared in both arms.Peritoneal Cancer Index (PCI) Score Interim analyses: After 69 patients have been enrolled, up to 1.5 years This scale measures the extent of peritoneal cancer throughout the peritoneal cavity.
The range of this scale is from 0 to 39.
0 = no disease within the peritoneal cavity
0-9 = minimal disease
10-29 = moderate disease
30-39 = extensive disease
Lower values are considered a better outcome for the patient.
Will be compared in both arms.Detection Rate (DR) Interim analyses: After 69 patients have been enrolled, up to 1.5 years DR of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.
DR of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
DR of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.
Will be compared in both arms.The time of peritoneal metastasis diagnosed after radical surgery Interim analyses: After 69 patients have been enrolled, up to 1.5 years Will be compared in both arms.
Completeness of Cytoreduction (CC) Score Interim analyses: After 69 patients have been enrolled, up to 1.5 years The degree to which the disease was able to be excised during the procedure.
This scale ranges from CC0-CC3.
CC0 = all disease has been cleared, with no visible peritoneal carcinomatosis after CRS
CC1 = microscopic disease remains (Nodules persisting \< 2.5 mm after CRS)
CC2 = macroscopic disease remains (Nodules persisting between 2.5 mm and 2.5 cm)
CC3 = Substantial Macroscopic disease remains (Nodules persisting \> 2.5 cm)
Lower values are considered a better outcome, with CC0/1 classed as favourable and CC2/3 indicating an incomplete clearance of disease.
Will be compared in both arms.
Trial Locations
- Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China