ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

NCT04752930 | Unknown DMC

• 1 other identifier: SixthSunYetSen-ctDNA
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Peritoneal Metastases

Keywords

ctDNA

Outcome Measures

Primary Outcomes (1)

• Peritoneal Metastasis Free Survival (PMFS)

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

  Through study completion, up to 3 years

Secondary Outcomes (9)

• Detection Rate (DR)

  Interim analyses: After 69 patients have been enrolled, up to 1.5 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

• The time of peritoneal metastasis diagnosed after radical surgery

  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

Study Arms (2)

ctDNA monitoring

EXPERIMENTAL

ctDNA monitoring will be performed at protocol-specified intervals and requirement

Diagnostic Test: ctDNA monitoring

Imageology (SOC)

ACTIVE COMPARATOR

Imaging examination will be performed at protocol-specified intervals and requirement

Diagnostic Test: Imageology

Interventions

ctDNA monitoring DIAGNOSTIC_TEST

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.

ctDNA monitoring

Imageology DIAGNOSTIC_TEST

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.

Imageology (SOC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Hui Wang, MD, PhD

CONTACT

13926424886; wang89@mail.sysu.edu.cn

Tenghui Ma, MD, PhD

CONTACT

13560232462; austin_2004@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 12, 2021
• Study Start: August 24, 2020
• Primary Completion: September 24, 2023
• Study Completion: August 24, 2025
• Last Updated: February 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)