JMIR Res Protoc. 2015 Apr 14;4(2):e41. doi: 10.2196/resprot.4151.
Recently, two nonrandomized, prospective cohort studies used magnetic resonance imaging (MRI) to assess the circumferential resection margin to identify "good prognosis" rectal tumors eligible for primary surgery and have reported favorable outcomes.
The objective of this project was to conduct a Phase II trial to assess the safety and feasibility of MRI criteria to identify "good prognosis" rectal tumors eligible for primary surgery in the North American setting.
Patients with newly diagnosed primary rectal cancer attending surgical clinics at participating centers will be invited to participate in the study. The inclusion criteria for the study are: (1) diagnosis of rectal cancer (0-15 cm) from the anal verge on endoscopy and proximal extent of tumor at or below the sacral promontory on computed tomography (CT) or MRI; (2) meets all MRI criteria for "good prognosis" rectal tumor as defined by the study protocol; (3) 18 years or older; and (4) able to provide written consent. The initial assessment will include: (1) clinical and endoscopic examination of the primary tumor; (2) CT chest, abdomen, and pelvis; and (3) pelvic MRI. All potentially eligible cases will be presented at a multidisciplinary cancer conference to assess for eligibility based on the MRI criteria for "good prognosis" tumor which include: (1) predicted circumferential resection margin (CRM) > 1 mm; (2) definite T2, T2/early T3, or definite T3 tumor with < 5 mm of extramural depth of invasion (EMD); (3) any N0, N1, or N2; and (4) absence of extramural venous invasion (EMVI). All patients fulfilling the MRI criteria for "good prognosis" rectal cancer and the inclusion and exclusion criteria will be invited to participate in the study and proceed to primary surgery. The safety of the MRI criteria will be evaluated by assessing the positive CRM rate and is the primary outcome for the study.
We expect to have a minimum of 300 potentially eligible patients, and based on a 30% eligibility rate and 80% participation rate, it is expected that 75 patients will be recruited over the two year study period. A Data Safety Monitoring Committee has been organized, and the study will be stopped if a positive CRM of >10% is reported at any interim assessment, which will occur after every 25 patients accrued in the study.
It is expected that the results of this study will show that use of MRI criteria to identify "good prognosis" rectal cancers eligible for primary surgery will be safe (ie, positive margin less than 10%). Therefore, these results will have significant potential to change the current management of rectal cancer in North America and result in improved quality of life for rectal cancer patients and survivors, while reducing overall health care costs.
ISRCTN05107772; http://www.controlled-trials.com/ISRCTN05107772/ (Archived by WebCite at http://www.webcitation/6WhhUhXkA).
最近，两项非随机前瞻性队列研究使用磁共振成像（MRI）评估环周切缘，以确定适合一期手术的“预后良好”的直肠肿瘤，并报告了良好的结果。
本项目的目的是进行一项II期试验，以评估在北美环境下，使用MRI标准识别适合一期手术的“预后良好”直肠肿瘤的安全性和可行性。
将邀请在参与中心的外科诊所就诊的新诊断原发性直肠癌患者参加本研究。本研究的纳入标准为：（1）内镜检查诊断为距肛缘0-15 cm的直肠癌，计算机断层扫描（CT）或MRI显示肿瘤近端范围在骶岬或其以下；（2）符合研究方案定义的“预后良好”直肠肿瘤的所有MRI标准；（3）年龄18岁及以上；（4）能够提供书面同意书。初始评估将包括：（1）对原发性肿瘤进行临床和内镜检查；（2）胸部、腹部和骨盆CT；（3）盆腔MRI。所有潜在符合条件的病例将在多学科癌症会议上进行展示，以根据“预后良好”肿瘤的MRI标准评估其是否符合条件，这些标准包括：（1）预测环周切缘（CRM）>1 mm；（2）明确的T2、T2/早期T3或明确的T3肿瘤，壁外浸润深度（EMD）<5 mm；（3）任何N0、N₁或N₂；（4）无壁外静脉侵犯（EMVI）。所有符合“预后良好”直肠癌MRI标准以及纳入和排除标准的患者将被邀请参加本研究并进行一期手术。将通过评估阳性CRM率来评估MRI标准的安全性，这是本研究的主要结局。
我们预计至少有300名潜在符合条件的患者，基于30%的符合率和80%的参与率预计在两年的研究期间将招募75名患者。已组建数据安全监测委员会，如果在任何中期评估中报告阳性CRM>10%，研究将停止，中期评估将在研究中每累积25名患者后进行。
预计本研究结果将表明，使用MRI标准识别适合一期手术的“预后良好”直肠癌将是安全的（即阳性切缘小于10%）。因此，这些结果将有很大潜力改变北美目前直肠癌的管理方式，提高直肠癌患者和幸存者的生活质量，同时降低总体医疗保健成本。
ISRCTN05107772；http://www.controlled-trials.com/ISRCTN05107772/（由WebCite存档于http://www.webcitation/6WhhUhXkA）
