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

Fudan University

Status and phase: Not yet enrolling; Phase 3

Conditions: Circulating Tumor Cell; Colorectal Cancer

Treatments: Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04917289

ZSCTC3

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.

Treatment:

Drug: Chemotherapy

Control Arm

No Intervention group

Description:

Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear.