Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer (NCT00690924) | Clinical Trial Compass
CompletedNot Applicable
Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
United States16 participantsStarted 2008-07-17
Plain-language summary
RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the lungs.
PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in preventing lung cancer in current smokers and former smokers at high risk of lung cancer.
Who can participate
Age range
40 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Pathologically confirmed squamous metaplasia or squamous dysplasia of the lungs by autofluorescence bronchoscopy within the past 5 years
* Must be a current or former smoker
* No evidence of concurrent disease with lung cancer or head and neck cancer
* History of treated lung cancer or head and neck cancer treated with curative intent allowed, provided that there has been no evidence of disease for \> 1 year
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Total granulocyte count \> 1,500 x 10\^9cells/L
* Platelet count \> 100,000 x 10\^9cells/L
* Calculated Creatinine clearance \> 60 mL/min (using the Cockcroft-Gault formula)
* Calcium concentration 50-300 mg/24 hours
* Total bilirubin 0.2-1.3 mg%
* ALT/AST ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Albumin ≥ 2.5 g/dL
* Ionized serum calcium normal (1.19-1.29 mmol/L)
* Corrected serum calcium ≤ 10.2 mg/dL
* Willing to attend all scheduled study visits, complete all study questionnaires, and allow biological specimen collection, including a bronchoscopy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 1 month after completion of study therapy
* No life-threatening medical conditions that would preclude bronchoscopy, including but not limited to, any of the following:
* Acute cardiac failure
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Unstable …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks