An observational study in Radiation; Adverse Effect, Pneumonitis, sponsored by Instituto Nacional de Cancerologia de Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Instituto Nacional de Cancerologia de Mexico · Observational
Lung cancer [LC] is the leading cause of cancer death worldwide. The standard treatment of locally advanced lung cancer unresectable or marginally resectable is combination therapy with radical or preoperative chemoradiation. The local control rates and survival with this treatment modality have increased by more than 30%. Radiotherapy [RT] with technical molded 3D [3D-CRT, Three-Dimensional Conformal Radiation Therapy] or IMRT [intensity-modulated radiation therapy] has allowed that the total dose of radiation has increased which leads to a direct benefit on the results treatment.
Between 17-30% of patients are susceptible to pneumonitis due to radiation [NR]. This complication may appear at the end of the RT or up to 6 months after the treatment. In severe cases, mortality can reach 50%.
It's well known that in various diseases, functional abnormalities precede the clinical manifestations. The degree of pulmonary failure secondary to RT is measured following the standards of the Radiation Therapy Oncology Group who ranks in degrees [0 to 4].
Not precisely known factors that influence the development of NR.
Objectives:
To evaluate the effect of chemotherapy and thoracic radiotherapy on pulmonary function and identify predictors of radiation pneumonitis in locally advanced lung cancer [stages IIIA and IIIB].
Hypothesis:
Respiratory function tests may predict the development of radiation pneumonitis in patients with locally advanced lung cancer who receive radical treatment with chemoradiation.
Methods Prospective cohort study with patients with locally advanced lung cancer of the Lung Cancer Clinic of the National Cancer Institute [INCAN]. Patients will receive weekly paclitaxel 50 mg and carboplatin AUC 2 with concomitant radiotherapy 44-63 Gy (22-33 fractions). Followup of lung function tests at baseline, during treatment with radiotherapy and will be carried out on 4 more occasions.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 62 is below the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Instituto Nacional de Cancerologia de Mexico is the lead sponsor of 41 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with locally advanced lung cancer candidates to receive treatment with chemoradiation that will receive treatment in the National Cancer Institute in Mexico City.
Exclusion criteria:
Patients with locally advanced lung cancer who are candidates to chemoradiation
Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients.
Time frame: January 2012 to December 2014
Plan to share: Yes
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cancerologia de Mexico