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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
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Detailed Description:


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 Design

Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Primary Completion Date : December 2015
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

locally advanced lung cancer
Patients with locally advanced lung cancer who are candidates to chemoradiation

Outcome Measures

Primary Outcome Measures :
  1. Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients. [ Time Frame: January 2012 to December 2014 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with locally advanced lung cancer candidates to receive treatment with chemoradiation that will receive treatment in the National Cancer Institute in Mexico City.

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.
  • History of previous radiotherapy to the primary site.
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580579

Instituto Nacional de Cancerología de México
Mexico city, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
National Council of Science and Technology, Mexico
Principal Investigator: Oscar Arrieta, MD Instituto de Cancerología
More Information

Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Chief of Thoracic Oncology Department, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01580579     History of Changes
Other Study ID Numbers: INCANOGAR2012-JA2
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
Radiation pneumonitis
locally advanced lung cancer
Respiratory function tests

Additional relevant MeSH terms:
Radiation Pneumonitis
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries