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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Patients who undergoing radical surgery for colorectal cancer for 6\~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled, and diagnostic laparoscopy will be performed immediately after enrollment. Patients with positive peritoneal metastasis (PCI score \<20) will be treated with CRS+HIPEC. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months in patients with negative peritoneal metastasis. Laparoscopy will be performed when imaging suggested peritoneal metastasis (oligometastases). Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.
Patients who undergoing radical surgery for colorectal cancer for 6\~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled. and there will be no need to conduct endoscopic exploration immediately after enrollment. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months until imaging suggested peritoneal metastasis (oligometastases). Patients with positive peritoneal metastasis (PCI score \<20) will be treated with CRS+HIPEC. Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGPeritoneal Metastasis Free Survival (PMFS)
The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.
Time frame: Through study completion, up to 3 years
Detection Rate (DR)
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.
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Positive Percent Agreement (PPA)
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.
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Negative Percent Agreement (NPA)
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.
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The time of peritoneal metastasis diagnosed after radical surgery
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Will be compared in both arms.
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Peritoneal Cancer Index (PCI) Score
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.
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Completeness of Cytoreduction (CC) Score
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.
Time frame: Interim analyses: After 69 patients have been enrolled, up to 1.5 years
The ctDNA clearance rate before and after CRS+HIPEC treatment
Will be compared in both arms.
Time frame: 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
Whether the patient is still alive and free of disease or not. Will be compared in both arms.
Time frame: Through study completion, up to 3 years
The Overall Survival (OS) at 3 years after radical resection of colorectal cancer
Whether the patient is still alive or not. Will be compared in both arms.
Time frame: Through study completion, up to 3 years