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

Phase 2

Withdrawn

• Conditions: Radiotherapy; Colorectal Cancer; Liver Metastases
• Interventions: Drug: Chemotherapy; Radiation: adjuvant SBRT

• Registration Number: NCT03135652
• Lead Sponsor: Wuhan Union Hospital, China

Brief 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.

Detailed Description

Liver metastases are detected in 40-50% of patients diagnosed with colorectal cancer. Local treatments like surgical resection or radiofrequency ablation result in 5-year survival of 35%. However, relapse still occurs in 70% of patients. Stereotactic body radiotherapy (SBRT) has emerged as a valid treatment not only to provide excellent symptom palliation, but also is effective in local control of metastatic lesions and improves survival. The potential efficacy of SBRT as adjuvant radiotherapy in CRLM patients after surgical resection or radiofrequency ablation is still unknown.

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-01
• Study Start: 2017-08-01
• Primary Completion: 2021-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-31
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemotherapy	Chemotherapy	chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
chemoradiotherapy	adjuvant SBRT	radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
chemoradiotherapy	Chemotherapy	radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Primary Outcome Measures

Name	Time	Method
Disease free survival	2 years	Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	To evaluate overall survival after consolidative SBRT in comparison to observation alone
Toxicities	2 years	Acute toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria during and up to 3 months after radiotherapy. Late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for the Research and Treatment of Cancer (EORTC) criteria.
Intrahepatic disease free survival	2 years	To evaluate Intrahepatic disease free survival after consolidative SBRT in comparison to observation alone

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China