Circulating Tumor Cell, Colorectal Cancer
Conditions
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.
Interventions
DRUGChemotherapy
Started chemotherapy or change the current adjuvant therapy
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 year | Time from randomization to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 3 year | Disease free time from randomization to death or recurrence |
| Adverse event | 1 year | CTCAE adverse event of chemotherapy |
Contacts
Primary ContactJianmin Xu
Outcome results
None listed