Brain NeoplasmNCT00178295
Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury
An observational study of Brain Neoplasm, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Neoplasm
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who are going to receive radiation therapy as part of the treatment for their brain cancer
Who may be able to join
- 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).
Who cannot join
- Patients who have a malignancy involving the hypothalamic-pituitary ax
- Patients who are not treated with irradiation to the brain or spinal axis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Dept. Radiation Oncology
Rochester, New York, 14642
About this study
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.
- Conditions
- Brain Neoplasm
- Being tested
- Radiation Therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
standard of care for the cancer being treated
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Cytokine blood levels
Measured: 12 weeks from start of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 1999
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Constine, University of Rochester
- Investigators
- Louis S Constine, MD, Study chair, Universtiy of Rochester, Dept of Radiation OncologyRalph Brasacchio, MD, Study chair, University of Rochester, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178295
- Sponsor's protocol ID
- URCC 11095
- Status last verified
- Aug 2015
- First submitted
- 12 Sep 2005
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury
- ClinicalTrials.gov ID
- NCT00178295
- Acronym / sponsor ID
- URCC 11095
- Conditions
- Brain Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 1999
- Primary completion
- Dec 2013 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who are going to receive radiation therapy as part of the treatment for their brain cancer
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients who have a malignancy involving the hypothalamic-pituitary ax
- Patients who are not treated with irradiation to the brain or spinal axis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation Therapystandard of care for the cancer being treated | Radiation | – |
Primary outcome
Change from baseline in Cytokine blood levels
Time frame: 12 weeks from start of radiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis S Constine, MD study chair
Universtiy of Rochester, Dept of Radiation Oncology
Ralph Brasacchio, MD study chair
University of Rochester, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasm, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Cytokine blood levels (time frame: 12 weeks from start of radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.