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CTC 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
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 2, 2021
    Last Updated
    June 2, 2021
    Sponsor
    Fudan University
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    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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