Status:
RECRUITING
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Collaborating Sponsors:
Instituto Nacional de Enfermedades Respiratorias
Conditions:
Radiation Pneumonitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 cand...
Detailed Description
Clinical evaluation The following BASELINE data shall be taken prior to radiation therapy: Demographic, clinical, laboratory, and imaging data will be obtained from medical history and electronic re...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03803787
Start Date
September 1 2018
End Date
December 1 2025
Last Update
May 1 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080
2
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico, 14080