Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178295
First received: September 12, 2005
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment of tumors with X-rays. This study is related to understanding the side effects of radiation treatment for brain tumors.

This study is being conducted by the University of Rochester Cancer Center to compare the extent of side effects of brain cancer treatment with changes in levels of blood proteins called cytokines.


Condition Intervention
Brain Neoplasm
Radiation: Radiation Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change from baseline in Cytokine blood levels [ Time Frame: 12 weeks from start of radiation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood plasma


Enrollment: 44
Study Start Date: November 1999
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radiation Therapy
    standard of care for the cancer being treated
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient who are going to receive radiation therapy as part of the treatment for their brain cancer

Criteria

Inclusion Criteria:

  • Any patient who will be treated to the brain or spinal axis for a CNS tum Patients so treated will be stratified according to whether or not the hypo is included in the treatment fields.
  • Patients receiving external beam radiation to the brain may also be rece chemotherapy or interferon-beta. (Add. #1, 11-9-95)
  • Patients receiving high dose rate (stereotactic radiosurgery) are eligible.
  • Patients must sign a study specific informed consent meeting all federal a guidelines.
  • Patients of any age, including children, are eligible (Add. #3, 11/25/97).

Exclusion Criteria:

  • Patients who have a malignancy involving the hypothalamic-pituitary ax
  • Patients who are not treated with irradiation to the brain or spinal axis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178295

Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Study Chair: Louis S Constine, MD Universtiy of Rochester, Dept of Radiation Oncology
Study Chair: Ralph Brasacchio, MD University of Rochester, Department of Radiation Oncology
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00178295     History of Changes
Other Study ID Numbers: URCC 11095
Study First Received: September 12, 2005
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Trauma, Nervous System
Wounds and Injuries
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014