背景:肿瘤手术切除是四肢和躯干软组织肉瘤(STS)的标准护理,通常伴有术前或术后放射治疗(RT)。术前RT可以降低关节僵硬和纤维化的风险,但伤口并发症的发生率更高。低分割,在前瞻性试验中,术前RT可提供可接受的结果.质子束疗法(PBT)提供了减少对周围危险器官的剂量的手段,比如皮肤,骨头,软组织,和相邻接头,尚未在四肢和躯干肉瘤患者中进行研究。
方法:我们的研究名为“术前低分割原始N治疗四肢和Truncal软组织sarcOma(PRONTO)的前瞻性II期试验”是非随机的,前瞻性II期试验评估术前安全性和有效性,计划进行手术切除的四肢和躯干STS患者的高分割PBT。将包括东部合作组表现状态≤2的可切除四肢和躯干STS的成年患者,目的是增加40名患者。治疗将包括30Gy放射生物学等效的PBT,每隔一天交付5个部分,随后2-12周后进行手术切除。主要结果是根据加拿大国家癌症研究所Sarcoma2(NCIC-SR2)多中心试验定义的主要伤口并发症的发生率。次要目标包括晚期≥2级毒性的发生率,1年和2年无局部复发生存率和无远处转移生存率,功能结果,生活质量,和病理反应。
结论:PRONTO代表了评价在STS中使用低分割PBT的第一个试验。我们的目标是证明这种方法的安全性和有效性,并将我们的结果与先前试验确定的历史结果进行比较。鉴于质子中心数量少,可用性有限,PBT的短期疗程可能为治疗患者提供了机会,否则这些患者在几周内每天接受RT治疗时会受到限制.我们希望这项试验将导致转诊模式的增加,为患者提供便利和临床工作流程效率,并提供支持在此设置中使用PBT的证据。
背景:NCT05917301(注册23/6/2023)。
BACKGROUND: Oncologic surgical resection is the standard of care for extremity and truncal soft tissue sarcoma (STS), often accompanied by the addition of pre- or postoperative radiation therapy (RT). Preoperative RT may decrease the risk of joint stiffness and fibrosis at the cost of higher rates of wound complications. Hypofractionated, preoperative RT has been shown to provide acceptable outcomes in prospective trials. Proton beam therapy (PBT) provides the means to decrease dose to surrounding organs at risk, such as the skin, bone, soft tissues, and adjacent joint(s), and has not yet been studied in patients with extremity and truncal sarcoma.
METHODS: Our
study titled \"PROspective phase II
trial of preoperative hypofractionated protoN therapy for extremity and Truncal soft tissue sarcOma (PRONTO)\" is a non-randomized, prospective phase II
trial evaluating the safety and efficacy of preoperative, hypofractionated PBT for patients with STS of the extremity and trunk planned for surgical resection. Adult patients with Eastern Cooperative Group Performance Status ≤ 2 with resectable extremity and truncal STS will be included, with the aim to accrue 40 patients. Treatment will consist of 30 Gy radiobiological equivalent of PBT in 5 fractions delivered every other day, followed by surgical resection 2-12 weeks later. The primary outcome is rate of major wound complications as defined according to the National Cancer Institute of Canada Sarcoma2 (NCIC-SR2) Multicenter
Trial. Secondary objectives include rate of late grade ≥ 2 toxicity, local recurrence-free survival and distant metastasis-free survival at 1- and 2-years, functional outcomes, quality of life, and pathologic response.
CONCLUSIONS: PRONTO represents the first
trial evaluating the use of hypofractionated PBT for STS. We aim to prove the safety and efficacy of this approach and to compare our results to historical outcomes established by previous trials. Given the low number of proton centers and limited availability, the short course of PBT may provide the opportunity to treat patients who would otherwise be limited when treating with daily RT over several weeks. We hope that this
trial will lead to increased referral patterns, offer benefits towards patient convenience and clinic workflow efficiency, and provide evidence supporting the use of PBT in this setting.
BACKGROUND: NCT05917301 (registered 23/6/2023).