Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Recruiting now · Phase 2
Conditions studied: Radiation Pneumonitis
In brief
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.
Key facts
- Study ID
- NCT03803787
- Run by
- Instituto Nacional de Cancerologia de Mexico
- People needed
- 72
- Starts
- 2018-09-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease.
- Patients treated with systemic or inhaled corticosteroids.
- Patients of reproductive age without a family planning method, pregnant or lactating.
- Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale.
- Patients with disease progression.
- Inspiratory flow < 90 liters / min.
- Discontinue of Treatment
Where it is running
- Instituto Nacional de Cancerologia — Mexico City, Mexico (enrolling)
- Instituto Nacional de Enfermedades Respiratorias — Mexico City, Mexico
Full record on ClinicalTrials.gov
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