UNASSIGNED: The HYACINCT study is a two-phase study to determine the effectiveness and safety of HF-RT with nSIB in LACC when ChT is contraindicated. Phase 1 is a dose-escalation study using standard 3 + 3 design, to determine the maximum tolerated dose (MTD) for nSIB in combination with pelvic HF-RT (2.67 Gy x 15 fractions). Phase 2 is a single-arm clinical trial using Simon\'s two-stage design, to assess the efficacy of HF-RT with nSIB in terms of tumor response. Adult women with biopsy-proven, untreated LACC, with contraindication to ChT will be included in this trial.
UNASSIGNED: For the phase 1, the primary endpoint is dose-limiting toxicity (DLT), or any grade ?3 acute or sub-acute toxicity. The dose level at which incidence of DLT is ?33% is defined as the maximum tolerance dose (MTD). For the phase 2, the primary endpoint is complete response at 3 months post-treatment. Secondary outcomes are progression-free and overall survival, acute and late toxicity, and patient-reported outcomes (EPIC, EORTCQLQ C30 + CX24, PGIC, PCIS). Trial registration: NCT05210270.
UNASSIGNED:HYACINCT研究是一项两阶段研究,旨在确定在ChT禁忌时在LACC中使用nSIB的HF-RT的有效性和安全性。第一阶段是使用标准3+3设计的剂量递增研究,确定nSIB联合盆腔HF-RT的最大耐受剂量(MTD)(2.67Gyx15分)。第二阶段是使用Simon的两阶段设计的单臂临床试验,评估HF-RT与nSIB在肿瘤反应方面的疗效。经活检证实的成年女性,未经处理的LACC,与ChT的禁忌症将包括在本试验中。
未经评估:对于第一阶段,主要终点是剂量限制性毒性(DLT),或任何3级急性或亚急性毒性。DLT发生率为33%的剂量水平定义为最大耐受剂量(MTD)。对于2期,主要终点是治疗后3个月的完全反应。次要结局是无进展和总生存期,急性和晚期毒性,和患者报告的结果(EPIC,EORTCQLQC30+CX24、PGIC、PCIS)。试用注册:NCT05210270。