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
  Purpose

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
Radiation; Adverse Effect, Pneumonitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients. [ Time Frame: January 2012 to December 2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
locally advanced lung cancer
Patients with locally advanced lung cancer who are candidates to chemoradiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580579

Contacts
Contact: Oscar G. Arrieta Rodriguez, MD 00525532236247 ogar@servidor.unam.mx
Contact: Jorge A. Alatorre Alexander, MD 00525529002732 drjorgealatorre@yahoo.com.mx

Locations
Mexico
Instituto Nacional de Cancerología de México Recruiting
Mexico city, Mexico, 14000
Contact: Oscar G. Arrieta Rodriguez, MD    00525532236247    ogar@servidor.unam.mx   
Contact: Jorge A. Alatorre Alexander, MD    00525529002732    drjorgealatorre@yahoo.com.mx   
Sub-Investigator: Luis Torre Bouscoulet, MD         
Principal Investigator: Oscar G Arrieta Rodriguez, MD         
Sub-Investigator: Jose R Perez Padilla, MD         
Sub-Investigator: María C García Sancho Figueroa, MD         
Sub-Investigator: Jorge A Alatorre Alexander, MD         
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Oscar Arrieta, MD Instituto de Cancerología
  More Information

No publications provided

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
Study First Received: April 17, 2012
Last Updated: June 12, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Radiation pneumonitis
locally advanced lung cancer
Respiratory function tests

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

ClinicalTrials.gov processed this record on August 19, 2014