Colorectal Cancer, Liver Metastases, Radiotherapy
Conditions
Keywords
Radiotherapy, Colorectal Cancer, Liver Metastases
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.
Interventions
RADIATIONadjuvant SBRT
adjuvant SBRT of liver lesions
DRUGChemotherapy
mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
adjuvant radiotherapy:SBRT chemotherapy:mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 2 years | Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | To evaluate overall survival after consolidative SBRT in comparison to observation alone |
| Intrahepatic disease free survival | 2 years | To evaluate Intrahepatic disease free 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. |
Countries
China
Outcome results
None listed