Impact of Hyperthermic Intrathoracic Chemotherapy (HITHOC) and Pleurectomy in the local treatment of pleural tumors. A Prospective Randomized Study The Tic-Tac Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The primary endpoint is progression-free survival. The comparison will be performed between the treatment group (HITHOC, n = 32) and the control group (chemical pleurodesis or indwelling pleural catheter placement, n = 32).
研究概览
简要总结
The primary objective is to compare hyperthermic intrathoracic chemotherapy, with or without pleurectomy, versus standard treatment (chemical pleurodesis or indwelling pleural catheter placement) in terms of progression-free survival (PFS) in a population of 64 patients affected by malignant pleural effusion.
研究设计
- 分配方式
- Randomized
- 主要目的
- Enrolment of Eligible Patients
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years
- •Scheduled diagnostic thoracoscopy for malignant pleural effusion
- •Good general clinical conditions (LENT score 1–2)
排除标准
- •Presence of active pulmonary or systemic infection
- •● Presence of any condition that, in the investigator’s judgment, may jeopardize the subject’s well-being and/or negatively affect the interpretation of data collected during the clinical study;
- •Inability to comply with study requirements or the follow-up schedule
结局指标
主要结局
The primary endpoint is progression-free survival. The comparison will be performed between the treatment group (HITHOC, n = 32) and the control group (chemical pleurodesis or indwelling pleural catheter placement, n = 32).
The primary endpoint is progression-free survival. The comparison will be performed between the treatment group (HITHOC, n = 32) and the control group (chemical pleurodesis or indwelling pleural catheter placement, n = 32).
次要结局
- Comparison of quality of life
- Comparison of overall survival
- Comparison of progression-free survival in patients with isolated parietal pleural disease undergoing HITHOC plus pleurectomy versus HITHOC alone through a second randomization
- Assessment of the accuracy and prognostic correlation of the intraoperative pleural disease dissemination score. This endpoint will be measured in all the patientsi
研究者
Francesco Leo
Scientific
Universita' Degli Studi Di Torino