Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Bevacizumab; Cetuximab

Criteria

Inclusion Criteria:

1. Biopsy proven unresectable metastatic colorectal cancer (CRC)

2. Primary resection of colorectal cancer (CRC)

3. Age≥18 years

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

5. Absence of evidence of extra-hepatic diseases

6. 1 to 3 liver metastases with an individual maximum diameter of up to 5 cm

7. Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed

8. Aspartate aminotransferase, alanine aminotransferase & alkaline phosphates must be ≤ 2.5 times of the upper limit of normal. Total bilirubin must be within the limit of normal.

9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3.

10. Patients must provide verbal and written informed consent to participate in the study.

11. Absence of any severe pulmonary or cardiac diseases

Exclusion Criteria:

1. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible

2. Patients who are pregnant

3. Patients with severe organ dysfunction

4. History of liver radiotherapy

5. Unwillingness to participate or inability to comply with the protocol for the duration of the study

6. Participation in any investigational drug study within 3 months preceding the start of study treatment

7. Patients not suitable to take part in clinical trials judged by researches