Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Key facts
- Where
- Mexico City, MexicoSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Mexico
- Instituto Nacional de CancerologiaMexico City, MexicoTaking people
- Instituto Nacional de Enfermedades RespiratoriasMexico City, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Nacional de Cancerologia de Mexico
- Trial code
- NCT03803787
- Record updated
- 8 April 2026
- Original description
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.Read full original descriptionShow less
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients
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.
Inclusion: Patients with non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the classification tumor node, metastasis (TNM) of malignant lung tumors, 7th edition; NSCLC patients candidates for concomitant treatment (chemotherapy plus radiotherapy or target therapy plus radiotherapy); Evidence of measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, Karnofsky 70-100; Life expectancy of > 4 months at the time of screening; Patients with the ability to comply with the study and follow-up procedures; Patients with previous surgery less than four weeks; Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
Exclusion: Patients treated with systemic or inhaled corticosteroids; Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale; Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease; Patients with disease progression; Patients of reproductive age without a family planning method, pregnant or lactating; Inspiratory flow < 90 liters / min; Discontinue of Treatment.