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

Fudan University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Colorectal Cancer Circulating Tumor Cell

Interventions

ChemotherapyDRUG

Started chemotherapy or change the current adjuvant therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival

Time from randomization to death

Time frame: 3 year

Secondary Outcomes

Disease free survival

Disease free time from randomization to death or recurrence

Time frame: 3 year

Adverse event

CTCAE adverse event of chemotherapy

Time frame: 1 year

Central Contacts

Jianmin Xu

CONTACT

+8613501984869 xujmin@aiiyun.com

Data from ClinicalTrials.gov

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