Cytoreductive Surgery and Hyperthermic Intrathoracic Chemotherapy for the Treatment of Thymic Epithelial Malignancies With Pleural Spread or Recurrence (CHOICE): a Prospective, Open, Single-arm Study Choice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- treatment-related adverse events and complications
研究概览
简要总结
Hyperthermic intrathoracic chemotherapy (HITOC) offers an additional treatment option for malignant pleural tumors after surgical cytoreduction. Especially it is used to further improve local tumor control in thymic malignancies with pleural spread, who underwent multimodality therapy including surgical resection. A phase II clinical study was conducted to explore the efficacy and safety of surgery followed by HITOC (POD1: DOX, POD2: cisplatin) for thymic epithelial tumors with pleural spread or recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Puncture biopsy, thoracoscopic/mediastinal biopsy, or surgery to confirm pathologically thymic epithelial tumor (TETs)
- •Imaging examination shows TETs with pleural spread or recurrence, and the mediastinal MDT team considers HITOC suitable.
- •Patients with ≥16 and ≤80 years old.
- •The patients should have no functional disorders in the main organs.
- •There was no history of other malignant carcinomas.
- •The duration from the last chemotherapy was >4 weeks, the duration from the last radiotherapy was >6 weeks, and the duration from the last immunotherapy was >6 weeks.
- •Not allergic to cisplatin or doxorubicin.
- •The patients should be able to understand our research and sign the informed consent.
排除标准
- •Imaging or pathological examination shows TETs without pleural spread or recurrence, or with pericardial dissemination or extrathoracic metastasis.
- •Patients with lymphoid system, neurogenic or reproductive system carcinoma.
- •Patients who have been receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
- •Patients with myasthenia gravis in unstable or acute exacerbation stage.
- •The patients have been proven history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control.
- •The patients have the severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under-treatment of thrombolysis or anticoagulant therapy.
- •Female who is positive for a serum pregnancy test or during lactation period.
- •The patients have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation.
- •The patients have a history of peripheral nerve system disorders, obvious mental disorders, or central nerve system disorders.
- •The patients attend other clinical trials.
结局指标
主要结局
treatment-related adverse events and complications
时间窗: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0.
Postoperative hospital stay
时间窗: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage \< 200 ml/day, a normal chest X-ray, and good physical condition.
EORTC QLQ-C30 score for overall quality of life
时间窗: Up to the end of follow-up since the date of randomization, up to 6 months.
Overall quality of life is respectively evaluated at randomization and 1 month, 3 month, 6 month after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Scale (EORTC QLQ-C30) (V3.0). The minimum value of EORTC QLQ-C30 score was 0， and the maximum was 100. Zero indicates the worst quality of life, while 100 represents the best quality of life.
次要结局
- Volume of postoperative drainage(Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days)
- Overall survival (OS)(Through study completion, an average of 5 year)
- Progression-free survival (PFS)(Through study completion, an average of 5 year)
- Visual Analog Scales scores for postoperative pain(from 0 to 72 hours after surgery)