NCT00178295

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

14.1 years

First QC Date

September 12, 2005

Last Update Submit

August 3, 2015

Conditions

Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Cytokine blood levels

    12 weeks from start of radiation

Interventions

Radiation TherapyRADIATION

standard of care for the cancer being treated

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Patients who have a malignancy involving the hypothalamic-pituitary ax
  • Patients who are not treated with irradiation to the brain or spinal axis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Louis S Constine, MD

    Universtiy of Rochester, Dept of Radiation Oncology

    STUDY CHAIR

  • Ralph Brasacchio, MD

    University of Rochester, Department of Radiation Oncology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 1999

Primary Completion

December 1, 2013

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(1)