Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Time to disease progression
研究概览
简要总结
Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation therapy the only treatment options. This study intends to evaluate whether surgical removal of all visible tumor on the chest wall followed by bathing the chest cavity in heated chemotherapy solution will improve outcomes for these advanced cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years
- •Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis.
- •Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer)
- •Adequate liver and renal function defined as a bilirubin of < 2.0 mg/dl, albumin > 3.0g/dl, and a creatinine of < 1.5 mg/dl, respectively.
- •Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm
- •A Karnofsky Performance Status score of ≥60
排除标准
- •Patients without satisfactory oncological control of their primary cancer.
- •Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease.
- •Chemotherapy and/or radiotherapy must have been completed at least one month prior to entry in the study. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy, or any investigational drugs while participating in this study.
- •Significant active medical disease including, but not limited to:
- •Cardiac disease, including: congestive heart failure or angina pectoris; recent (within 1 year) history of a myocardial infarction; uncontrolled hypertension; arrhythmias.
- •Active infections
- •Uncontrolled diabetes mellitus
- •Chronic renal insufficiency
- •HIV/AIDS - routine HIV testing will not be performed, but patients known to be HIV positive will be excluded.
- •Pregnant or lactating women.
- •Allergy to intravenous contrast
结局指标
主要结局
Time to disease progression
时间窗: 1 year
Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the time to disease progression of this experimental treatment modality.
Survival
时间窗: 1 year
Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the overall survival period following treatment with this experimental modality.
次要结局
- Systemic drug absorption(1 month)
- Complications(1 month)
研究者
Gary Schwartz
MD
St. Luke's-Roosevelt Hospital Center