Actively Recruiting
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2026-04-08
72
Participants Needed
2
Research Sites
482 weeks
Total Duration
On this page
Sponsors
I
Instituto Nacional de Cancerologia de Mexico
Lead Sponsor
I
Instituto Nacional de Enfermedades Respiratorias
Collaborating Sponsor
AI-Summary
What this Trial Is About
This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT. The main questions it aims to answer are: Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales. Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.
CONDITIONS
Official Title
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the tumor node metastasis (TNM) classification, 7th edition.
- NSCLC patients who are candidates for concomitant chemotherapy plus radiotherapy or targeted therapy plus radiotherapy.
- Evidence of measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, Karnofsky score between 70 and 100.
- Life expectancy greater than 4 months at screening.
- Ability to comply with study and follow-up procedures.
- Previous surgery performed less than four weeks before enrolling.
- Willing and able to give signed informed consent and comply with protocol tests and procedures.
You will not qualify if you...
- Unstable systemic disease including active infection, heart, liver, kidney, or metabolic disease, and uncontrolled chronic lung disease.
- Current treatment with systemic or inhaled corticosteroids.
- Patients of reproductive age without family planning, pregnant or breastfeeding women.
- Previous diagnosis of pneumonitis with toxicity grade 2 or higher by CTCAE v4.0 or RTOG scale.
- Patients with disease progression.
- Inspiratory flow less than 90 liters per minute.
- Discontinuation of treatment.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080
Actively Recruiting
2
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico, 14080
Active, Not Recruiting
Research Team
O
Oscar Arrieta, MD MSc
CONTACT
D
Diana Flores
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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