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首页> 外文期刊>BMC Cancer >Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management
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Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management

机译：直肠腺癌的器官保存：一项II期随机对照试验，评估了局部晚期直肠癌患者的3年无病生存率，这些患者接受化学放疗，诱导或巩固化疗以及全直肠系膜切除或非手术治疗

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Background Treatment of patients with non-metastatic, locally advanced rectal cancer (LARC) includes pre-operative chemoradiation, total mesorectal excision (TME) and post-operative adjuvant chemotherapy. This trimodality treatment provides local tumor control in most patients; but almost one-third ultimately die from distant metastasis. Most survivors experience significant impairment in quality of life (QoL), due primarily to removal of the rectum. A current challenge lies in identifying patients who could safely undergo rectal preservation without sacrificing survival benefit and QoL. Methods/Design This multi-institutional, phase II study investigates the efficacy of total neoadjuvant therapy (TNT) and selective non-operative management (NOM) in LARC. Patients with MRI-staged Stage II or III rectal cancer amenable to TME will be randomized to receive FOLFOX/CAPEOX: a) before induction neoadjuvant chemotherapy (INCT); or b) after consolidation neoadjuvant chemotherapy (CNCT), with 5-FU or capecitabine-based chemoradiation. Patients in both arms will be re-staged after completing all neoadjuvant therapy. Those with residual tumor at the primary site will undergo TME. Patients with clinical complete response (cCR) will receive non-operative management (NOM). NOM patients will be followed every 3?months for 2?years, and every 6?months thereafter. TME patients will be followed according to NCCN guidelines. All will be followed for at least 5?years from the date of surgery or—in patients treated with NOM—the last day of treatment. Discussion The studies published thus far on the safety of NOM in LARC have compared survival between select groups of patients with a cCR after NOM, to patients with a pathologic complete response (pCR) after TME. The current study compares 3-year disease-free survival (DFS) in an entire population of patients with LARC, including those with cCR and those with pCR. We will compare the two arms of the study with respect to organ preservation at 3?years, treatment compliance, adverse events and surgical complications. We will measure QoL in both groups. We will analyze molecular indications that may lead to more individually tailored treatments in the future. This will be the first NOM trial utilizing a regression schema for response assessment in a prospective fashion. Trial registration NCT02008656
机译：背景技术非转移性局部晚期直肠癌（LARC）患者的治疗包括术前放化疗，全直肠系膜切除术（TME）和术后辅助化疗。这种三联疗法可为大多数患者提供局部肿瘤控制。但几乎三分之一的人最终死于远处转移。大多数幸存者的生活质量（QoL）受到严重损害，这主要是由于直肠切除所致。当前的挑战在于确定可以安全地进行直肠保存而不牺牲生存获益和生活质量的患者。方法/设计这项多机构的II期研究调查了LARC的总新辅助治疗（TNT）和选择性非手术治疗（NOM）的疗效。 MRI分期为TME的MRI分期的II期或III期直肠癌患者将被随机分配接受FOLFOX / CAPEOX：a）在诱导新辅助化疗（INCT）之前;或b）合并新辅助化疗（CNCT）后，以5-FU或卡培他滨为基础的化学放射治疗。完成所有新辅助治疗后，双臂患者将重新分期。在原发部位残留肿瘤的患者将接受TME治疗。具有临床完全缓解（cCR）的患者将接受非手术治疗（NOM）。 NOM患者每3个月随访2年，之后每6个月随访一次。将根据NCCN指南对TME患者进行随访。从手术之日起，或者在接受NOM治疗的患者中，至少要在治疗的最后一天对其进行至少5年的随访。讨论迄今为止发表的有关LARC中NOM安全性的研究已经比较了NOM后cCR的特定患者组与TME后具有病理完全反应（pCR）的患者之间的生存期。目前的研究比较了整个LARC患者（包括cCR患者和pCR患者）的3年无病生存期（DFS）。我们将比较研究的两个方面，即3年内器官的保存，治疗依从性，不良事件和手术并发症。我们将测量两组的QoL。我们将分析可能在将来导致更多个性化治疗的分子适应症。这将是第一个使用回归模式以预期方式进行回归评估的NOM试验。试用注册NCT02008656

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