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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Circulating Tumor Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Arm

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

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

Started chemotherapy or change the current adjuvant therapy

Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chemotherapy

Started chemotherapy or change the current adjuvant therapy

Intervention Type DRUG

Eligibility Criteria

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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