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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01580579
First received: April 17, 2012
Last updated: June 12, 2013
Last verified: June 2013

April 17, 2012
June 12, 2013
July 2012
December 2014   (final data collection date for primary outcome measure)
Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients. [ Time Frame: January 2012 to December 2014 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01580579 on ClinicalTrials.gov Archive Site
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Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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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.

Radiation; Adverse Effect, Pneumonitis
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locally advanced lung cancer
Patients with locally advanced lung cancer who are candidates to chemoradiation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Oscar G. Arrieta Rodriguez, MD 00525532236247 ogar@servidor.unam.mx
Contact: Jorge A. Alatorre Alexander, MD 00525529002732 drjorgealatorre@yahoo.com.mx
Mexico
 
NCT01580579
INCANOGAR2012-JA2
No
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
Instituto Nacional de Cancerologia de Mexico
National Council of Science and Technology, Mexico
Principal Investigator: Oscar Arrieta, MD Instituto de Cancerología
Instituto Nacional de Cancerologia de Mexico
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP