Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, 03722, Seoul, Republic of Korea.
BMC Cancer. 2023 Oct 20;23(1):1014. doi: 10.1186/s12885-023-11407-y.
Efforts have been made to investigate the role of salvage radiotherapy (RT) in treating recurrent ovarian cancer (ROC). Stereotactic ablative radiation therapy (SABR) is a state-of-the-art therapy that uses intensity modulation to increase the fractional dose, decrease the number of fractions, and target tumors with high precision.
The SABR-ROC trial is a phase 3, multicenter, randomized, prospective study to evaluate whether the addition of SABR to the standard of care significantly improves the 3-year overall survival (OS) of patients with ROC. Patients who have completed the standard treatment for primary epithelial ovarian cancer are eligible. In addition, patients with number of metastases ≤ 10 and maximum diameter of each metastatic site of gross tumor ≤ 5 cm are allowed. Randomization will be stratified by (1) No. of the following clinical factors met, platinum sensitivity, absence of ascites, normal level of CA125, and ECOG performance status of 0-1; 0-3 vs. 4; (2) site of recurrence; with vs. without lymph nodes; and (3) PARP inhibitor; use vs. non-use. The target number of patients to be enrolled in this study is 270. Participants will be randomized in a 1:2 ratio. Participants in Arm 2 will receive SABR for recurrent lesions clearly identified in imaging tests as well as the standard of care (Arm 1) based on treatment guidelines and decisions made in multidisciplinary discussions. The RT fraction number can range from 1 to 10, and the accepted dose range is 16-45 Gy. The RT Quality Assurance (QA) program consists of a three-tiered system: general credentialing, trial-specific credentialing, and individual case reviews.
SABR appears to be preferable as it does not interfere with the schedule of systemic treatment by minimizing the elapsed days of RT. The synergistic effect between systemic treatment and SABR is expected to reduce the tumor burden by eradicating gross tumors identified through imaging with SABR and controlling microscopic cancer with systemic treatment. It might also be beneficial for quality-of-life preservation in older adults or heavily treated patients.
This trial was registered at ClinicalTrials.gov (NCT05444270) on June 29th, 2022.
人们一直在努力探讨挽救性放疗（RT）在治疗复发性卵巢癌（ROC）中的作用。立体定向消融放疗（SABR）是一种采用强度调制技术来提高分次剂量、减少分次次数、并以高精度靶向肿瘤的先进治疗方法。
SABR-ROC 试验是一项 3 期、多中心、随机、前瞻性研究，旨在评估在 ROC 患者的标准治疗中添加 SABR 是否显著提高 3 年总生存率（OS）。符合以下条件的患者有资格入组：完成原发性上皮性卵巢癌标准治疗的患者；转移灶数量≤10 个且每个转移灶的最大直径≤5cm 的患者。分层因素包括：（1）符合以下临床因素的数量，铂类敏感性、无腹水、CA125 水平正常、ECOG 体能状态 0-1；0-3 与 4；（2）复发部位；淋巴结与非淋巴结；（3）PARP 抑制剂；使用与非使用。该研究计划入组 270 名患者。采用 1:2 的随机分组方式。Arm2 组的患者将接受明确在影像学检查中识别出的复发性病变的 SABR 治疗，以及基于治疗指南和多学科讨论做出的标准治疗（Arm1）。放疗分割次数可以是 1 到 10 次，接受的剂量范围是 16-45Gy。放疗质量保证（QA）计划包括三级系统：一般认证、特定试验认证和个别病例审查。
SABR 似乎是更好的选择，因为它通过最大限度地减少放疗的延误天数，不干扰系统治疗的计划。通过 SABR 消灭影像学检查识别的大体肿瘤，并通过系统治疗控制微观癌症，预计系统治疗和 SABR 之间的协同作用将降低肿瘤负担。它可能对保留老年或接受过多治疗的患者的生活质量也有益。
该试验于 2022 年 6 月 29 日在 ClinicalTrials.gov（NCT05444270）注册。
