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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04917289
• Other study ID #: ZSCTC3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2021
• Source: Fudan University
• Contact: Jianmin Xu
• Phone: +8613501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplastic Cells, Circulating
• Recurrence

Intervention

Drug:
• Chemotherapy
Started chemotherapy or change the current adjuvant therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time from randomization to death	3 year
Secondary	Disease free survival	Disease free time from randomization to death or recurrence	3 year
Secondary	Adverse event	CTCAE adverse event of chemotherapy	1 year