Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

本项III期临床试验针对最多累及4个身体部位的局限性转移性结直肠癌患者，对比消融联合全身治疗方案与单纯常规全身治疗方案的治疗效果。未参与本研究的患者常规治疗方案为静脉输注（intravenous, IV）及/或口服药物（全身疗法，systemic therapy），旨在阻止癌灶增大及癌症向其他身体部位进一步扩散。消融治疗指通过局部治疗手段清除该转移灶处的癌细胞。本次研究采用的局部消融治疗将包含聚焦强化放疗，即立体定向消融放疗（stereotactic ablative radiotherapy, SABR），可联合或不联合手术切除及/或微波消融术（microwave ablation）；该术式指将穿刺针临时置入肿瘤组织，通过高温破坏癌细胞的操作。立体定向消融放疗、手术切除及微波消融均已完成安全性验证，但目前尚无科学证据表明，添加上述治疗手段对该分期的癌症患者具有临床获益。在常规全身疗法基础上，对所有已明确的转移灶追加局部消融治疗，或可缩小甚至清除肿瘤，或预防肿瘤复发。