Back to resultsctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
Primary Purpose
Colorectal Cancer, Peritoneal Metastases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ctDNA monitoring
Imageology
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring ctDNA
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.
Sites / Locations
- Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ctDNA monitoring
Imageology (SOC)
Arm Description
ctDNA monitoring will be performed at protocol-specified intervals and requirement
Imaging examination will be performed at protocol-specified intervals and requirement
Outcomes
Primary Outcome Measures
Peritoneal Metastasis Free Survival (PMFS)
The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.
Secondary Outcome Measures
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.
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.
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.
The time of peritoneal metastasis diagnosed after radical surgery
Will be compared in both arms.
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.
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.
The ctDNA clearance rate before and after CRS+HIPEC treatment
Will be compared in both arms.
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.
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.
Full Information
NCT ID
NCT04752930
First Posted
January 26, 2021
Last Updated
February 9, 2021
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04752930
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
September 24, 2023 (Anticipated)
Study Completion Date
August 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Peritoneal Metastases
Keywords
ctDNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ctDNA monitoring
Arm Type
Experimental
Arm Description
ctDNA monitoring will be performed at protocol-specified intervals and requirement
Arm Title
Imageology (SOC)
Arm Type
Active Comparator
Arm Description
Imaging examination will be performed at protocol-specified intervals and requirement
Intervention Type
Diagnostic Test
Intervention Name(s)
ctDNA monitoring
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Imageology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peritoneal Metastasis Free Survival (PMFS)
Description
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
Secondary Outcome Measure Information:
Title
Detection Rate (DR)
Description
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
Title
Positive Percent Agreement (PPA)
Description
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
Title
Negative Percent Agreement (NPA)
Description
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
Title
The time of peritoneal metastasis diagnosed after radical surgery
Description
Will be compared in both arms.
Time Frame
Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Title
Peritoneal Cancer Index (PCI) Score
Description
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
Title
Completeness of Cytoreduction (CC) Score
Description
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
Title
The ctDNA clearance rate before and after CRS+HIPEC treatment
Description
Will be compared in both arms.
Time Frame
Interim analyses: After 69 patients have been enrolled, up to 1.5 years
Title
The rate of Disease Free Survival (DFS) at 3 years after radical resection of colorectal cancer
Description
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
Title
The Overall Survival (OS) at 3 years after radical resection of colorectal cancer
Description
Whether the patient is still alive or not.
Will be compared in both arms.
Time Frame
Through study completion, up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wang, MD, PhD
Phone
13926424886
Email
wang89@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tenghui Ma, MD, PhD
Phone
13560232462
Email
austin_2004@163.com
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
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