Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation
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|ClinicalTrials.gov Identifier: NCT01580579|
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : March 3, 2017
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.
|Condition or disease|
|Radiation; Adverse Effect, Pneumonitis|
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].
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.
|Study Type :||Observational|
|Actual Enrollment :||62 participants|
|Official Title:||Clinical, Biochemical, Dosimetric and Functional Respiratory Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer (Stages IIIa and IIIb) Treated With Chemotherapy and Radiotherapy|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
locally advanced lung cancer
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 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580579
|Instituto Nacional de Cancerología de México|
|Mexico city, Mexico, 14000|
|Principal Investigator:||Oscar Arrieta, MD||Instituto de Cancerología|