NCT01487499终止3 期
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Solid Tumor Growth After Completion of Interventional Bronchoscopies
研究概览
简要总结
This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:
- to implement a prospective clinical trial to test the feasibility and efficacy of intralesional chemotherapy as consolidative therapy immediately following standard systemic chemotherapy and radiation therapy for patients with limited stage SCLC by comparing tumor growth and survival rates of the treatment group and compare the outcomes to historical controls
- to implement a prospective clinical trial to test the feasibility and efficacy as measured by tumor growth and survival rates of intralesional chemotherapy for patients with recurrent SCLC after standard treatment.
详细描述
Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome measurements of tumor growth and survival will be compared to subjects receiving standard of care treatment only.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent adult English speaking subjects
- •With limited stage SCLC who have completed standard of care treatment who are responders with no evidence of disseminated disease other than CNS metastasis,
- •With recurrent disseminated SCLC after standard of care treatment with symptoms related to central tumor obstruction,
- •With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously treated with intratumoral cisplatin
排除标准
- •Subjects who do not meet the inclusion criteria
- •Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy
研究组 & 干预措施
patients with limited stage SCLC
Experimental
Subjects with limited stage SCLC treated sequentially with cisplatin.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Solid Tumor Growth After Completion of Interventional Bronchoscopies
时间窗: 18 months
The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.
次要结局
- Overall Survival(5 years)
- Progression-free Survival(18 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
早期 1 期
Bronchoscopic Cryo-Immunotherapy of Lung CancerAdvanced Non-small Cell Lung CancerNCT04049474NYU Langone Health21
招募中
1 期
In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to LungLung MetastasesColorectal Cancer MetastaticColorectal CancerNCT05611034University Health Network, Toronto10
招募中
不适用
CLE-guided bronchoscopy for peripheral lung cancer diagnosis: a Randomized Controlled TrialPeripheral lung cancer10038666NL-OMON53986Academisch Medisch Centrum45
进行中（未招募）
3 期
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)Small Cell Lung CancerNCT04624204Merck Sharp & Dohme LLC672
Unknown
2 期
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung CancerNon Small Cell Lung CancerNCT01305967SBPharmaceutical IND, Co., LTD20