Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC) (SCLC)
|ClinicalTrials.gov Identifier: NCT01487499|
Recruitment Status : Terminated (Unable to enroll adequate number of participants)
First Posted : December 7, 2011
Results First Posted : March 25, 2015
Last Update Posted : June 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Cisplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer|
|Study Start Date :||December 2011|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
Experimental: patients with limited stage SCLC
Subjects with limited stage SCLC treated sequentially with cisplatin.
40 mg in 40 mL of normal saline for each of 4 bronchoscopies
No Intervention: Historical Controls
- Solid Tumor Growth After Completion of Interventional Bronchoscopies [ Time Frame: 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.
- Progression-free Survival [ Time Frame: 18 months ]
- Overall Survival [ Time Frame: 5 years ]Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487499
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Michael A. Jantz, MD||University of Florida|