Oligometastases of the Liver Treated With Chemotherapy With or Without Radiotherapy in Patients With Colorectal Cancer — OLIVER  

Colorectal Cancer Clinical Trial

Official title: Oligometastases of the LIVer Treated With Chemotherapy With or Without Extracranial Stereotactic Body Radiation Therapy in Patients With Colorectal Cancer

Status Not yet recruiting

Clinical Trial Summary

Colorectal cancer is a major cause of morbidity and mortality throughout the world and accounts for more than 9% of all cancer outcomes. Global mortality from colorectal cancer is approximately half the incidence. An estimated 394,000 colorectal cancer deaths occur worldwide each year, making colorectal cancer the fourth most common cause of cancer death. Overall survival rates after surgical resection of hepatic colorectal metastases were 10-18% higher than in patients treated with systemic therapy. Hepatic metastases occur in 45% of patients with colorectal cancer. Surgery is the standard of care for resectable diseases, with overall survival rates of 5 years (OS) of 28% -58%. Unfortunately, only 10-20% of patients have a resectable disease at the time of diagnosis. The current approach to treating nonresectable metastatic colorectal cancer (mCRC) promotes the use of combined cytotoxic therapy. First-line treatments include cytotoxic combinations. The role of radiotherapy in metastatic cancer is historically palliative, conventional radiotherapeutic techniques causing radiation-induced liver disease (RLID). With the advent of extracranial stereotactic radiotherapy (SBRT), equivalent doses can be safely administered in 3 to 5 fractions, which can result in the removal of all affected tissues in the treated area while limiting the irradiation of the host organ and the healthy tissues surrounding the tumors. The efficacy and safety of SBRT for liver metastases has been confirmed by retrospective studies showing local control rates of about 80% or more. Retrospective studies indicate that approximately 20% of patients remain disease-free 2 to 4 years after SBRT. For patients treated with SBRT, some authors found that half of the patients had no metastatic progression or very little progression in numbers and metastasis sites. These results confirm the idea of an oligometastatic state in which aggressive local therapy could improve progression-free survival (PFS). We propose in this study to evaluate the impact of SBRT on progression-free survival in patients with mCRC with 1-3 oligometastases of the liver. Two arms will be compared: the standard arm treated with chemotherapy; to the experimental arm combining chemotherapy and SBRT. The chemotherapy will be left free at the choice of the investigator according to the recommendations of national treatments.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Neoplasm Metastasis
• Radiation Therapy

• NCT number: NCT03296839
• Study type: Interventional
• Source: UNICANCER
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2017
• Completion date: January 2023