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

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. Identifier: NCT00690924
Recruitment Status : Active, not recruiting
First Posted : June 5, 2008
Results First Posted : October 11, 2017
Last Update Posted : January 8, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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

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

calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study

Participant Flow:   Overall Study

  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.
All treated and eligible patients

Reporting Groups

calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      12  75.0% 
>=65 years      4  25.0% 
[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

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

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

Responsible Party: Roswell Park Cancer Institute 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: January 8, 2018