2026-525406-36-00招募中2 期
Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The percentage of patients with local or peritoneal disease recurrence within 36 months after surgery.
研究概览
简要总结
Evaluation of the impact of HIPEC on the incidence of local or peritoneal recurrences of ACC, assessed through clinical examinations, blood biochemical tests, and thoraco-abdominal CT scan (with and without contrast) performed every 4 months, according to standard clinical practice.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and females ≥18 years of age
- •Patients with preoperative diagnosis of ACC ENS@T stage II or III
- •No previous treatments for ACC except for mitotane.
- •Multidisciplinary indication to upfront surgery
- •Women of child-bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study;
- •Women must not be breastfeeding;
- •Willing and able to comply with clinic visits and study-related procedures;
- •Willing and able to provide informed consent signed by study patient or legally acceptable representative.
排除标准
- •Exploratory procedures or procedure conducted not according to the technical guidelines for regional adrenalectomy;
- •If the histological diagnosis after surgery will indicate a tumor histotype other than ACC, the patient will be dropped from the study.
- •Diagnosis other than ACC at histological examination;
- •Patients with ENS@T stage I or IV tumors;
- •Patients with ad ECOG performance status >1;
- •Intercurrent clinical conditions, such as uncontrolled infections or heart failure, that prevent the surgical procedure from being performed
- •Patients with extensive inferior vena cava thrombosis requiring vascular replacement or extracorporeal circulation procedures;
- •Continued sexual activity in women of childbearing potential or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) for at least 6 months after the HIPEC;
- •Refusal to sign the informed consent;
结局指标
主要结局
The percentage of patients with local or peritoneal disease recurrence within 36 months after surgery.
The percentage of patients with local or peritoneal disease recurrence within 36 months after surgery.
次要结局
- Percentage of patients with major perioperative morbidity (grade > 2 according to the Clavien-Dindo classification of surgical complications).
- Postoperative mortality rates at 30 and 90 days.
- Disease-specific survival up to 3 years after surgery.
研究者
S.C. Clinical Trial Center
Scientific
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
研究点 (1)
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