2025-523482-23-00招募中2 期
PITALC. Pilot study on the effect of PITAC (Pressurized IntraThoracic Aerosol Chemotherapy) by videothoracoscopy in patients with malignant pleural effusion in the light of the results of a retrospective historical cohort treated with talc pleurodesis by videothoracoscopy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the percentage of recurrence of pleural effusion assessed at 1 month by chest X-ray. Recurrence of pleural effusion is defined by a higher ipsilateral pleural effusion at 1 month compared to hospitalization discharge.
研究概览
简要总结
To study the effect of PITAC (Pressurized IntraThoracic Aerosol Chemotherapy) on malignant pleural effusion recurrence in unresectable pleural carcinomatosis patients, regardless of primary malignancy tumor
研究设计
- 分配方式
- Na
- 主要目的
- Treatment
- 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
- •Male or female ≥ 18 years old
- •Patient with malignant pleural effusion with prior histological or cytological diagnostic OR patient with suspected pleural effusion, proven by frozen section
- •Patient with unresectable pleural carcinomatosis whatever the presence of other metastatic site and whatever the diagnosis of the primary malignancy
- •Patient who has given free and written informed consent
- •Patient affiliated to a social health insurance or assimilated
排除标准
- •Patient with a history of videothoracoscopy talc pleurodesis for malignant pleural effusion
- •Patient benefiting from a legal protection measure (guardianship or curatorship)
- •Persons deprived of their liberty by a judicial or administrative decision
- •Patient with altered general condition (Karnofsky score <70 or Performance Status> 2) according to the investigator
- •Patient with contraindication to general anesthesia
- •Patient eligible for curative surgical treatment (cytoreduction + HITHOC) (limited parietal pleural involvement, limited and peripheral visceral pleural involvement without another metastatic site)
- •Patient with contraindication to doxorubicin and cisplatin: allergy/hypersensitivity to the product or excipients, association with live attenuated vaccines, association with olaparib, association with phenytoin, myelosuppression or organ failure
- •Patient with contraindication to cisplatin only: auditory damage, cisplatin-induced neuropathy, renal impairment defined as GFR < 40 mL/min (Cockcroft-Gault equation) or impaired bone marrow function defined as platelets ≤ 100 G/L
- •Patient with contraindication to doxorubicin only: severe arrhythmia, myocardial insufficiency defined as NYHA class >2 or Left Ventricular Ejection Fraction (LVEF) < 50%
- •Female patients who are pregnant, lactating or women or men of child-bearing potential without highly effective methods of contraception during the treatment for men and women, during 4 months after end of treatment for men and during 7 months after end of treatment for women
- •Patient participating in another interventional study likely to interfere with this study
结局指标
主要结局
the percentage of recurrence of pleural effusion assessed at 1 month by chest X-ray. Recurrence of pleural effusion is defined by a higher ipsilateral pleural effusion at 1 month compared to hospitalization discharge.
the percentage of recurrence of pleural effusion assessed at 1 month by chest X-ray. Recurrence of pleural effusion is defined by a higher ipsilateral pleural effusion at 1 month compared to hospitalization discharge.
次要结局
- Assessment of dyspnea using the MMRC scale at 1, 3, 6 and 12 months.
- Postoperative complications according to Clavien classification at 3 months.
- Percentage of patients for whom PITAC is fully completed, percentage of patients for whom PITAC is partially completed and percentage of patients for whom PITAC is finally not performed.
- Overall survival, defined as the delay between PITAC and death. Patients alive at the last assessment will be censored. Estimate will be given at 12 months
- Adverse events with assessment at each 12-month follow-up period: renal, hepatic or hematological toxicity, lung injury, acute respiratory distress syndrome, prolonged air leak, hemothorax, wound reopening, pulmonary hernia and toxic emphysema. An independent data safety monitoring board (DSMB) will monitor the safety of the study and make recommendations regarding its continuation
- Assessment of quality of life using the EORTC QLQ-C30 questionnaire at 1 and 3 months.
- Percentage of patients with local disease control according to chest CT scan at 3 months. The local disease progression at 3 months is assessed by pleural effusion (more significant) and/or the appearance or progression of pleural nodules (number or volume) compared to inclusion.
- Percentage of recurrence of pleural effusion and mean change of maximum diameter of the pleural effusion assessed at 1 month by pleural ultrasound. Recurrence of pleural effusion is defined by a higher ipsilateral pleural effusion at 1 month compared to hospitalization discharge.
- Ancillary endpoint: Same endpoints as those used for the assessment of the PITAC strategy (see criteria above).
研究者
Dr Gabrielle Drevet
Scientific
Hospices Civils De Lyon
研究点 (1)
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