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Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178230
First Posted: September 15, 2005
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuhchyau Chen, University of Rochester
  Purpose
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.

Condition
Lung Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity in Thoracic Malignancies

Resource links provided by NLM:


Further study details as provided by Yuhchyau Chen, University of Rochester:

Enrollment: 82
Actual Study Start Date: March 15, 1996
Study Completion Date: November 25, 2013
Primary Completion Date: November 25, 2013 (Final data collection date for primary outcome measure)
  Eligibility

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 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.
Criteria

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

  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): NCT00178230


Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Yuhchyau Chen, MD, Ph.D Universtiy of Rochester, Dept of Radiation Oncology
  More Information

Responsible Party: Yuhchyau Chen, Proffessor, University of Rochester
ClinicalTrials.gov Identifier: NCT00178230     History of Changes
Other Study ID Numbers: URCC 4595
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: June 14, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases