Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

This study has been terminated.
(Unable to enroll adequate number of participants)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01487499
First received: December 1, 2011
Last updated: March 16, 2015
Last verified: March 2015
Results First Received: March 16, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Intervention: Drug: Cisplatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients With Limited Stage SCLC

Subjects with limited stage SCLC treated sequentially with cisplatin.

Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies


Participant Flow:   Overall Study
    Patients With Limited Stage SCLC  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patients With Limited Stage SCLC

Subjects with limited stage SCLC treated sequentially with cisplatin.

Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies


Baseline Measures
    Patients With Limited Stage SCLC  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures

1.  Primary:   Solid Tumor Growth After Completion of Interventional Bronchoscopies   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael A. Jantz, MD
Organization: University of Florida
phone: 352-273-8737
e-mail: michael.jantz@medicine.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01487499     History of Changes
Other Study ID Numbers: SCLC
Study First Received: December 1, 2011
Results First Received: March 16, 2015
Last Updated: March 16, 2015
Health Authority: United States: Institutional Review Board