Clinical, Biochemical, Dosimetric and Functional Respiratory Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer (Stages IIIa and IIIb) Treated With Chemotherapy and Radiotherapy
18 Years
N/A
Both
Radiation; Adverse Effect, Pneumonitis
Trial Information
Clinical, Biochemical, Dosimetric and Functional Respiratory Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer (Stages IIIa and IIIb) Treated With Chemotherapy and Radiotherapy
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.
Inclusion Criteria:
- Candidates must have understood and signed informed consent
- Histopathological diagnosis of locally advanced lung cancer [IIIA-cT2N1-2, cT3N1-2,
cT4N0, M0o IIIB: cT2N3, cT3N3, cT4N1-3, M0]. They may also include patients with
oligometastatic disease[M1] candidates for chemoradiation
- Any histology
- Medical tests: white blood cell count ≥ plasma 3,000 / mm3, platelets ≥ 100,000 / mm
3, hemoglobin ≥ 12 g / dl, serum creatinine ≤ 1.5 mg / dl, total bilirubin ≤ 1.5,
transaminases [ ≤ 2.5 times the upper limit of normal [ULN], alkaline phosphatase <5
ULN.
- Age ≥ 18 years.
- General condition score according to ECOG 0 to 2 or a ≥ 60% Karnofsky.
- Estimated life expectancy with treatment of at least 24 weeks.
Exclusion criteria:
- Uncontrolled concurrent diseases.
- Have received radiotherapy to the primary site or prior chemotherapy.
- Pregnant or breast-feeding.
- Use of anticoagulants in therapeutic doses
- Intercurrent Malignancies, except dormant basal cell carcinoma in skin, carcinoma in
situ of the cervix
- Invasive cancer unless the background was at least 5 years and the disease-free
status.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients.
Outcome Time Frame:
January 2012 to December 2014
Safety Issue:
No
Principal Investigator
Oscar Arrieta, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Instituto de Cancerología
Authority:
Mexico: Ethics Committee
Study ID:
INCANOGAR2012-JA2
NCT ID:
NCT01580579
Start Date:
July 2012
Completion Date:
December 2014
Related Keywords:
- Radiation; Adverse Effect, Pneumonitis
- Radiation pneumonitis
- locally advanced lung cancer
- Respiratory function tests
- Lung Neoplasms
- Pneumonia
- Radiation Pneumonitis
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