Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer|
- Solid tumor growth after completion of interventional bronchoscopies [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]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: evaluate survival rates for 18 months ] [ Designated as safety issue: Yes ]The RECIST system will be used to grade response to therapy
- Overall survival [ Time Frame: for 5 years ] [ Designated as safety issue: Yes ]follow subjects for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487499
|Contact: Michael Jantz, MD||(866) firstname.lastname@example.org|
|Contact: Pamela Schreck, RN MSNemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Michael A. Jantz, MD 866-229-6312 firstname.lastname@example.org|
|Contact: Pamela J. Schreck, RN MSN (866) 229-6312 email@example.com|
|Principal Investigator: Michael Jantz, MD|
|Sub-Investigator: Frederic Kaye, MD|
|Sub-Investigator: Eugene Goldberg, PhD|
|Principal Investigator:||Michael A. Jantz, MD||University of Florida|