CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients

Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection

This study enrolled patients who underwent R0 resection of tumor and had elevated tumor biomarkers (CEA, CA19-9). After enroll the study, a CTC test will performed and patients who had positive CTC will be randomly assigned to two groups. The control group will continue follow-up until radiological recurrence appear, the treatment group will start treatment or change the current adjuvant regimen. First endpoint is OS. The secondary endpoint is DFS, adverse event.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Circulating Tumor Cell
• Intervention / Treatment: Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianmin Xu; Phone Number: +8613501984869; Email: xujmin@aiiyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-80 years;

Histologically proven colorectal cancer

All the lesion (s) has been R0 resected

Have elevated tumor biomarker (CEA or CA19-9) in three consecutive tests

More than 1 CTC has been detected (including 1)

ECOG 0-1

Hematology tests suggest that they can tolerate chemotherapy

Written informed consent for participation in the trial

Exclusion Criteria:

• Have any radiological evidence of recurrence

Other previous malignancy within 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.	Drug: Chemotherapy; Started chemotherapy or change the current adjuvant therapy
No Intervention: Control Arm; Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Time from randomization to death	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Disease free time from randomization to death or recurrence	3 year
Adverse event	CTCAE adverse event of chemotherapy	1 year

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Neoplasm Metastasis; Colorectal Neoplasms; Recurrence; Neoplastic Cells, Circulating
• Other Study ID Numbers: ZSCTC3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No