NCT02153229进行中（未招募）2 期
A Randomized Phase 2 Trial of Radical Pleurectomy and Post-Operative Chemotherapy With or Without Intraoperative Porfimer Sodium -Mediated Photodynamic Therapy for Patients With Epitheliod Malignant Pleural Mesothelioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Survival months
研究概览
简要总结
A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic diagnosis of MPM, epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor.
- •Patients must have disease limited to the hemithorax.
- •Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment.
- •Subjects treated with pemetrexed previously will be eligible only if 30 days have elapsed between the last dose of pemetrexed and the date of surgery.
- •ECOG performance status of 0-
- •Medical suitability for resection, including documented medical and cardiac clearance.
- •18 years of age or older.
- •Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable due to cognitive impairment to sign informed consent are excluded from the study.
- •EXCLUSION CRITERIA
- •Patients with active invasive cancers, other than MPM, that require additional treatment, except non-melanomatous skin cancer, superficial bladder or cervical cancer, and early-stage prostate cancer
- •Pregnant or lactating patients.
- •Patients who have a history of HIV disease.
- •Patients who have a white count less than 2,500 per cubic mm or platelets less than 100,000/cubic mm.
- •Serum creatinine equal or greater than 2.5 mg/deciliter.
- •Patients who have severe liver disease including cirrhosis, Grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/deciliter.
- •Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- •Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 30 days to the date of surgery.
- •Patients that have been treated with prior Mantle field radiation.
- •Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax.
- •Subjects who have received more than 2 doses of neo-adjuvant chemotherapy
排除标准
- 未提供
研究组 & 干预措施
patients who undergo RP plus photofrin-based PDT
Experimental
干预措施: Photodynamic Therapy (Radiation)
patients who undergo RP plus photofrin-based PDT
Experimental
干预措施: Radical Pleurectomy (Procedure)
patients who undergo RP plus photofrin-based PDT
Experimental
干预措施: Chemotherapy (Radiation)
patients who undergo RP plus photofrin-based PDT
Experimental
干预措施: Photofrin 2.0 mg/kg (Drug)
patients who undergo RP alone
Experimental
干预措施: Radical Pleurectomy (Procedure)
patients who undergo RP alone
Experimental
干预措施: Chemotherapy (Radiation)
结局指标
主要结局
Survival months
时间窗: 4 years
次要结局
- Receipt of Pembrolizumab(4 years)
- Progression-free survival months(4 years)
- Local Control(4 years)
研究者
研究点 (2)
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