Brain MetastasisPhase 2NCT01508221
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
A Phase 2 study testing Trental and Vitamin E in people with Brain Metastasis, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis
- What is being tested?
- Trental and Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 1 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
- Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
- Age > 18 years
- Partial or total resection of a metastatic tumor are eligible
Who cannot join
- Known sensitivity to vitamin E or Trental
- Recent intracranial bleed or retinal hemorrhage
- Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
- History of Avastin treatment
- Anticipated need for treatment with Avastin
- History of bleeding disorder
- History of liver disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.
Read the detailed description
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.
- Conditions
- Brain Metastasis
- Being tested
- Trental, Vitamin E
- Keywords
- brain metastasis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrentalDrug
Also called Pentoxifylline
400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months
Vitamin EDietary supplement
400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Trental + Vitamin E | Experimental | Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Receives: Drug: Trental; Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Symptomatic Radiation Necrosis
Number of symptomatic death of healthy tissue caused by radiation therapy.
Measured: average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJun 2011
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Marcum, University of Cincinnati
- Investigators
- Ronald Warnick, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508221
- Sponsor's protocol ID
- BTC-W1
- Status last verified
- Aug 2023
- First submitted
- 8 Jan 2012
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
- ClinicalTrials.gov ID
- NCT01508221
- Acronym / sponsor ID
- BTC-W1
- Conditions
- Brain Metastasis
- Keywords
- brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.
Detailed description
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trental + Vitamin E | Experimental | Drug: Trental, Dietary Supplement: Vitamin ETrental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
- Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
- Age > 18 years
- Partial or total resection of a metastatic tumor are eligible
Key exclusion criteria (7 listed)
- Known sensitivity to vitamin E or Trental
- Recent intracranial bleed or retinal hemorrhage
- Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
- History of Avastin treatment
- Anticipated need for treatment with Avastin
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 |
|---|---|---|
| TrentalAlso: Pentoxifylline400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months | Drug | Trental + Vitamin E |
| Vitamin E400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months | Dietary supplement | Trental + Vitamin E |
Primary outcome
Number of Participants With Symptomatic Radiation Necrosis
Time frame: average 1 year
Number of symptomatic death of healthy tissue caused by radiation therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ronald Warnick, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trental and Vitamin E in people with Brain Metastasis, run by University of Cincinnati 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 4 inclusion and 7 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 14 Sep 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Symptomatic Radiation Necrosis (time frame: average 1 year). 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 14 Sep 2023.