Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation

March 1, 2017 updated by: Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 14000
        • Instituto Nacional De Cancerologia de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
locally advanced lung cancer
Patients with locally advanced lung cancer who are candidates to chemoradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients.
Time Frame: January 2012 to December 2014
January 2012 to December 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Collaborators

National Council of Science and Technology, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCANOGAR2012-JA2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Radiation; Adverse Effect, Pneumonitis

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