Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation
|First Received Date ICMJE||April 17, 2012|
|Last Updated Date||April 18, 2012|
|Start Date ICMJE||July 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01580579 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation|
|Official Title ICMJE||Clinical, Biochemical, Dosimetric and Functional Respiratory Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer (Stages IIIa and IIIb) Treated With Chemotherapy and Radiotherapy|
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.
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).Follow up of lung function tests at baseline, during treatment with radiotherapy and will be carried out on 4 more occasions.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Patients with locally advanced lung cancer candidates to receive treatment with chemoradiation that will receive treatment in the national cancer institute in Mexico city.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||locally advanced lung cancer
Patients with locally advanced lung cancer who are candidates to chemoradiation
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||80|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Mexico|
|NCT Number ICMJE||NCT01580579|
|Other Study ID Numbers ICMJE||INCANOGAR2012-JA2|
|Has Data Monitoring Committee||No|
|Responsible Party||Oscar Gerardo Arrieta Rodriguez MD, Instituto Nacional de Cancerologia de Mexico|
|Study Sponsor ICMJE||Instituto Nacional de Cancerologia de Mexico|
|Collaborators ICMJE||National Council of Science and Technology, Mexico|
|Investigators ICMJE||Not Provided|
|Information Provided By||Instituto Nacional de Cancerologia de Mexico|
|Verification Date||April 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP