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出境医 / 临床实验 / CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients

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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Circulating Tumor Cell Drug: Chemotherapy Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2025
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 year ]
    Time from randomization to death


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 year ]
    Disease free time from randomization to death or recurrence

  2. Adverse event [ Time Frame: 1 year ]
    CTCAE adverse event of chemotherapy


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jianmin Xu +8613501984869 xujmin@aiiyun.com

Sponsors and Collaborators
Fudan University
Tracking Information
First Submitted Date  ICMJE June 2, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date June 8, 2021
Estimated Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021) 		Overall Survival [ Time Frame: 3 year ]
Time from randomization to death
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Disease free survival [ Time Frame: 3 year ]
    Disease free time from randomization to death or recurrence
  • Adverse event [ Time Frame: 1 year ]
    CTCAE adverse event of chemotherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients
Official Title  ICMJE Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colorectal Cancer
  • Circulating Tumor Cell
Intervention  ICMJE Drug: Chemotherapy
Started chemotherapy or change the current adjuvant therapy
Study Arms  ICMJE
  • Experimental: Treatment Arm
    Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.
    Intervention: Drug: Chemotherapy
  • No Intervention: Control Arm
    Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianmin Xu +8613501984869 xujmin@aiiyun.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04917289
Other Study ID Numbers  ICMJE ZSCTC3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP