米勒博士ERASur的主要目标是回答这个问题--如果我们用消融疗法（如手术、放疗和热消融）和标准化疗（一种全身疗法）治疗所有部位的疾病，还是仅用标准化疗治疗，局限性转移性结直肠癌患者的寿命是否更长？

对于只扩散到肝脏的 IV 期结直肠癌患者，我们知道同时采用消融治疗和全身治疗对转移性肿瘤有好处。但是，对于转移灶已扩散到肝脏以外部位或肝脏和身体其他部位均有转移的患者，我们不知道在全身治疗的同时对所有转移灶进行消融治疗是否有好处，或者仅用全身治疗就足以改善生存。

如果在全身治疗的基础上增加消融治疗，患者可能会花费不必要的额外时间和金钱前往就诊，或经历不必要的消融治疗副作用。

如果在全身治疗的基础上增加消融治疗，患者可能会花费不必要的额外时间和金钱前往就诊，或经历不必要的消融治疗副作用。

米勒博士患者可以在开始标准护理疗法（全身疗法）之前或完成 39 周全身疗法之前的任何时间进行预注册，从而提前参与研究。

The inclusion criteria for pre-registration are straightforward: a diagnosis of metastatic colorectal cancer either through a biopsy of the primary tumor or a metastatic site, the tumor must be microsatellite stable and BRAF V600E wild-type (no BRAF V600E mutation present), and no liver-only metastatic disease or peritoneal/omental metastasis.

Patients can register for the study as long as they have not developed new or enlarging metastases during initial systemic therapy, completed a minimum of 12 weeks and a maximum of 39 weeks of systemic therapy, and have 4 or fewer sites of disease remaining after initial systemic therapy on repeat imaging. A single “site” of disease is defined as each liver lobe (right and left), each lobe of the lungs, each adrenal gland, lymph nodes addressable in a single surgery or radiation field, and bone metastases that can be treated in a single radiation field. Importantly, there are no restrictions on the number of tumors per site. For example, if a patient has 3 tumors in the right lobe of the liver or 3 tumors in the right upper lobe of the lung, those are each considered one site of disease. The primary tumor also needs to be either already removed surgically or amenable to surgical removal.

截至 2024 年 8 月，该试验在以下各州开放：亚利桑那州、加利福尼亚州、佛罗里达州、佐治亚州、爱荷华州、爱达荷州、肯塔基州、马里兰州、密歇根州、明尼苏达州、密苏里州、密西西比州、蒙大拿州、北达科他州、内布拉斯加州、新泽西州、新墨西哥州、内华达州、纽约州、俄亥俄州、俄克拉荷马州、宾夕法尼亚州、南达科他州、田纳西州、得克萨斯州、犹他州、威斯康星州。

Dr. Miller: Following completion of initial systemic therapy (12-39 weeks), patients who meet eligibility criteria are randomized to either total ablative therapy (TAT) plus systemic therapy or systemic therapy alone. For patients in the TAT group, the treatment team will decide on which ablative therapies are appropriate to address all areas of disease. Those therapies may include surgical removal, stereotactic body radiation therapy (high doses of radiation delivered in a precise manner to ablate the tumor), and/or microwave ablation (focused heat to kill the tumor). Following TAT, it is left to the treatment team and patient to come to a joint decision about continued systemic therapy. In both the TAT group and the systemic therapy alone group, there is a lot of flexibility regarding treatment. Patients can continue systemic therapy, transition to maintenance systemic therapy, or go on a treatment break at any time.

米勒博士这项研究的主要终点是总生存期--比较 TAT 组和单纯系统治疗组患者的生存期。我们还有其他次要终点，包括无事件生存期、治疗毒性以及接受 TAT 治疗的患者转移性疾病的局部控制情况。值得注意的是，我们还将在研究中选择性地采集血液，并计划在未来进行ctDNA分析。

米勒博士将尽可能多的决定权留给治疗团队和患者，是我们使这项试验实用化的方法之一。我们还允许患者在离家较近的地方接受系统治疗，而不一定是在他们登记参加试验的地点，这有助于让那些居住地离试验地点不近的患者更容易参加试验。我要感谢曼朱和她在 COLONTOWN 的同事们为使这项试验真正成为一项务实的试验所做出的杰出贡献。

To continue learning about the ERASur trial, check this X (Twitter) thread by @CrcTrialsChat, with short videos with the three Principal Investigators, and also this DocTalk of Manju with them, posted on Colontown University.  You can also view this clinical trial in Fight CRC’s 临床试验搜索器.

致谢：ERASur试验的首席研究员：俄亥俄州立大学詹姆斯综合癌症中心转化治疗项目成员、消化道放射肿瘤学家 Eric Miller 博士；纽约纪念斯隆凯特琳癌症中心放射肿瘤部结直肠癌和肛门癌主任、放射肿瘤学家、早期药物开发专家 Paul Romesser 博士；佛罗里达大学健康癌症中心放射肿瘤部临床副教授 Kate Hitchcock 博士。

每月一次，Maia Walker 和 Manju George 将为我们的社区解读重要的研究试验、提示和建议。请务必订阅并注册 Fight CRC，加入 COLONTOWN 的在线社区，继续接收 CRC 世界中最相关的最新信息！

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov  for more information on trials.