Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer (NCT00321893) | Clinical Trial Compass
CompletedPhase 2
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
Italy225 participantsStarted 2006-01
Plain-language summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.
PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.
Who can participate
Age range
50 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.
Inclusion criteria
. Current smokers or former smokers that have stopped within the last 15 years
. Smoking history \> 20 pack/years
. Age \> 50 years
. Persistent lung nodules detected at Low dose computed tomography (LDCT) scan from previous year with 1 of the following:- longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1 \& 8 mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative PET scan, negative CT enhancement. Nodule should have grown with a doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
. Eastern Cooperative Oncology Group (ECOG) performance status \< 1 (Karnofsky \>60%)
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
Number CT- Detected Lung Nodules by Participant
Timeframe: Baseline assessment
2
Size of CT- Detected Lung Nodules by Participant
Timeframe: Baseline assessment
3
Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
Timeframe: 12 Months
4
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
. Participants must have normal organ and marrow function as defined below: Leukocytes \>3,000/mL, absolute neutrophil count greater than 1,500/mL, platelets greater than 100,000/mL, total bilirubin lower than 1.5 \* upper normal institutional limits, aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) lower than 1.5 \* upper normal institutional limits, creatinine lower than 1.5 \* upper normal institutional limits
. Females must be postmenopausal (ie, at least 1 year passed after the last menstruation), surgically sterile, or using acceptable contraceptive measures as judged by the Investigator. (A fertile woman is defined as being of child-bearing potential, from first menstruation to 1 year after last menstruation.). Negative serum beta-HCG for women of childbearing potential will be required at baseline. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
. More than 6 lung nodules (suspect of chronic granulomatous disease)
. Lung nodules with clearly benign morphological features at CT scan (i.e, homogenous calcification, solid nodules with regular and round or polygonal margins and distance from the pleura \<1cm)
. Subjects currently suffering from malignant disease or having had malignant disease within the last 5 years except for cervical carcinoma in situ and non melanoma skin cancer
. Regular/chronic use of oral or inhaled corticosteroids; regular use being defined as a total of 3 months cumulative use in the last 12 months
. Use of any other investigational agents at time of enrollment in the study during the three months preceding study enrollment
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to corticosteroid
. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Any other factor that at the investigator's discretion contraindicates the use of inhaled corticosteroids
. Pregnant or lactating females, or females planning to become pregnant during the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If needed, a pregnancy test will be performed on serum during baseline lab test