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

Phase 3

Not yet recruiting

• Conditions: Colorectal Cancer; Circulating Tumor Cell
• Interventions: Drug: Chemotherapy

• Registration Number: NCT04917289
• Lead Sponsor: Fudan University

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 available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-08
• Last Update Posted: 2021-06-08
• Primary Completion: 2023-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Have any radiological evidence of recurrence

Other previous malignancy within 5 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Chemotherapy	Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 year	Time from randomization to death

Secondary Outcome Measures

Name	Time	Method
Disease free survival	3 year	Disease free time from randomization to death or recurrence
Adverse event	1 year	CTCAE adverse event of chemotherapy