Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity

Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity in Thoracic Malignancies

This study is being conducted by the University of Rochester Cancer Center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester, Dept. Radiation Oncology

Participation Criteria

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 receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.

Description

Inclusion Criteria:

Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.

Patients receiving HDR Brachytherapy for lung cancer.

Patients receiving concomitant radiation and interferon therapy for lung cancer.

Patients receiving concomitant chemotherapy and radiation for lung cancer. Prior drug therapy does not make patients ineligible.

Karnofsky ≥ 70 %.

There are no age restrictions.

Acceptable bone marrow function - WBC 2 3000/mm3, platelet count > 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl.

Life expectancy > 6 months.

Patients must sign informed consent meeting all federal and institutional guidelines.

Exclusion Criteria:

Patients not meeting eligibility criteria stated above

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Yuhchyau Chen, MD, Ph.D, Universtiy of Rochester, Dept of Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 1996
• Primary Completion (Actual): November 25, 2013
• Study Completion (Actual): November 25, 2013

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: URCC 4595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No