Back to resultsCTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer, Circulating Tumor Cell
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Arm
Control Arm
Arm Description
Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.
Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear.
Outcomes
Primary Outcome Measures
Overall Survival
Time from randomization to death
Secondary Outcome Measures
Disease free survival
Disease free time from randomization to death or recurrence
Adverse event
CTCAE adverse event of chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04917289
Brief Title
CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients
Official Title
Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Circulating Tumor Cell
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Started chemotherapy or change the current adjuvant therapy
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization to death
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Disease free time from randomization to death or recurrence
Time Frame
3 year
Title
Adverse event
Description
CTCAE adverse event of chemotherapy
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu
Phone
+8613501984869
Email
xujmin@aiiyun.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients
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