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

Brain Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178295
• Other study ID #: URCC 11095
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 3, 2015
• Start date: November 1999

Study information

• Verified date: August 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms
• Trauma, Nervous System

Intervention

Radiation:
• Radiation Therapy
standard of care for the cancer being treated

Locations

Country	Name	City	State
United States	University of Rochester, Dept. Radiation Oncology	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Cytokine blood levels		12 weeks from start of radiation	No