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Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 1, 2027
    v8
  2. Primary and study completion dates: Dec 1, 2024 to Dec 1, 2025v7
  3. Primary completion date: Sep 1, 2024 to Dec 1, 2024v6
  4. Primary completion date: Sep 1, 2023 to Sep 1, 2024
    • Study completion date: Dec 1, 2023 to Dec 1, 2024
    v5
  5. Primary completion date: Dec 1, 2022 to Sep 1, 2023
    • Study completion date: Dec 1, 2022 to Dec 1, 2023
    • Study description shortened, about 220 words
    v4
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  1. Primary and study completion dates: Oct 1, 2021 to Dec 1, 2022v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03803787
Lead Sponsor Instituto Nacional de Cancerologia de Mexico
Collaborators: Instituto Nacional de Enfermedades Respiratorias
Conditions
(from sponsor)		 Radiation Pneumonitis
Related terms Carcinoma, Non-Small-Cell Lung, Lung Diseases, Lung Injury, Radiation Fibrosis Syndrome, Radiation Pneumonitis, Respiratory Tract Neoplasms, Thoracic Neoplasms
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov