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

NCT04917289 | Unknown Phase 3

• 1 other identifier: ZSCTC3
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from randomization to death

  3 year

Secondary Outcomes (2)

• Disease free survival

  3 year

• Adverse event

  1 year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Drug: Chemotherapy

Control Arm

NO INTERVENTION

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

Interventions

Chemotherapy DRUG

Started chemotherapy or change the current adjuvant therapy

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have any radiological evidence of recurrence
• Other previous malignancy within 5 years

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplastic Cells, Circulating

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jianmin Xu

CONTACT

+8613501984869; xujmin@aiiyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: June 8, 2021

Record last verified: 2021-04