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Trial record 1 of 1 for:    NCT00690924
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Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00690924
First Posted: June 5, 2008
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
Results First Submitted: July 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Lung Cancer
Precancerous Condition
Tobacco Use Disorder
Interventions: Drug: calcitriol
Other: laboratory biomarker analysis
Other: pharmacological study

  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
Calcitriol

calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study


Participant Flow:   Overall Study
    Calcitriol
STARTED   16 
COMPLETED   16 
NOT COMPLETED   0 



  Baseline Characteristics
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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.
All treated and eligible patients

Reporting Groups
  Description
Calcitriol

calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study


Baseline Measures
   Calcitriol 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12  75.0% 
>=65 years      4  25.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.1  (8.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  37.5% 
Male      10  62.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      16 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300
e-mail: Adrienne.Groman@RoswellPark.org



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00690924     History of Changes
Obsolete Identifiers: NCT01896804
Other Study ID Numbers: CDR0000596506
P30CA016056 ( U.S. NIH Grant/Contract )
I 90206
First Submitted: June 4, 2008
First Posted: June 5, 2008
Results First Submitted: July 13, 2017
Results First Posted: October 11, 2017
Last Update Posted: October 11, 2017