Clinical trial · Interventional
CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients
Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Patients in this arm will receive treatment or change current adjuvant therapy immediately after detecting CTC.
- interventionNames
- Drug: Chemotherapy
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Patients in this arm will keep follow-up after detecting CTC until radiology evidence of recurrence appear.
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 year
- description
- Time from randomization to death
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available