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

Huazhong University of Science and Technology

Status and phase: Withdrawn; Phase 2

Conditions: Radiotherapy; Liver Metastases; Colorectal Cancer

Treatments: Drug: Chemotherapy; Radiation: adjuvant SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03135652

CRLM-AR1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

chemoradiotherapy

Experimental group

Description:

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

Treatment:

Radiation: adjuvant SBRT

Drug: Chemotherapy

chemotherapy

Active Comparator group

Description:

chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Treatment:

Drug: Chemotherapy