Brain MetastasesPhase 1RAD 1002NCT01252797
Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
A Phase 1 study testing Stereotactic Radiosurgery (15 Gy) and Stereotactic Radiosurgery (12 Gy) in people with Brain Metastases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Stereotactic Radiosurgery (15 Gy) and Stereotactic Radiosurgery (12 Gy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2018
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
- Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry)
- At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon.
- Karnofsky performance status (KPS) of greater than or equal to 60
- Age greater than 19
- Life expectancy greater than 12 weeks
- Subjects given written informed consent
Who cannot join
- Patients with small cell lung cancer and lymphoma are ineligible.
- More than four metastases by baseline post-contrast MRI
- Prior whole brain radiation therapy
- Insufficient recovery from all active toxicities of prior therapies
- Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities
- Pregnant or nursing women
- Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.
Read the detailed description
This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (DLT).
Group A: Index Tumor > 2 cm and up to 4 cm in maximum diameter Group B: Index Tumor > 4 cm and up to 6 cm in maximum diameter
Dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. Group A will start at dose level II. Group B will start at dose level I.
Dose Level I: 12 Gy Dose Level II: 15 Gy
- Conditions
- Brain Metastases
- Being tested
- Stereotactic Radiosurgery (15 Gy), Stereotactic Radiosurgery (12 Gy)
- Keywords
- brain metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiosurgery (15 Gy)Radiation
Group A will start at dose level II: 15 Gy
Group B will start at dose level I: 12 Gy
Stereotactic Radiosurgery (12 Gy)Radiation
Group B will start at Dose Level I: 12 Gy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery (15 Gy) | Active comparator | Group A: If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter, then this group will receive Dose Level II (15 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor. Receives: Radiation: Stereotactic Radiosurgery (15 Gy) |
| Stereotactic Radiosurgery (12Gy) | Experimental | Group B: If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter, then this group will receive Dose Level I (12 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor. Receives: Radiation: Stereotactic Radiosurgery (12 Gy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis
The maximum tolerated dose (MTD) is defined as the highest dose of stereotactic radiosurgery delivered pre-operative at which no more than 2 out of 6 patients experience a dose limiting toxicity (DLT).
Measured: one year
Secondary outcomes (4)
Acute Toxicity with preoperative stereotactic radiosurgery (SRS)
Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring within six months or less from the date of stereotactic radiosurgery was received.
Measured: 6 months
Late Toxicity with preoperative stereotactic radiosurgery (SRS)
Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring more than six months from the date of stereotactic radiosurgery was received.
Measured: 1 year
Rates of Local Control
This will be assessed by MRI Imaging obtained post-operatively at follow-up visits.
Measured: 2 years
Rates of Leptomeningeal Dissemination
Leptomeningeal Dissemination (LMD) defined as diffuse carcinomatosis and/or distant focal pachymeningeal (dural) tumor and assessed by MRI Imaging for the study period.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fiveash, MD, University of Alabama at Birmingham
- Investigators
- John B. Fiveash, MD, Principal investigator, Hazelrig-Salter Radiation Oncology Center (HSROC)/ University of Alabama at Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252797
- Sponsor's protocol ID
- F100528006
- Acronym
- RAD 1002
- Status last verified
- May 2018
- First submitted
- 22 Nov 2010
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
- ClinicalTrials.gov ID
- NCT01252797
- Acronym / sponsor ID
- RAD 1002 / F100528006
- Conditions
- Brain Metastases
- Keywords
- brain metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 3 Dec 2010 (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.
This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.
Detailed description
This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (DLT).
Group A: Index Tumor > 2 cm and up to 4 cm in maximum diameter Group B: Index Tumor > 4 cm and up to 6 cm in maximum diameter
Dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. Group A will start at dose level II. Group B will start at dose level I.
Dose Level I: 12 Gy Dose Level II: 15 Gy
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery (15 Gy) | Active comparator | Radiation: Stereotactic Radiosurgery (15 Gy)Group A: If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter, then this group will receive Dose Level II (15 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor. |
| Stereotactic Radiosurgery (12Gy) | Experimental | Radiation: Stereotactic Radiosurgery (12 Gy)Group B: If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter, then this group will receive Dose Level I (12 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
- Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry)
- At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon.
- Karnofsky performance status (KPS) of greater than or equal to 60
- Age greater than 19
Key exclusion criteria (7 listed)
- Patients with small cell lung cancer and lymphoma are ineligible.
- More than four metastases by baseline post-contrast MRI
- Prior whole brain radiation therapy
- Insufficient recovery from all active toxicities of prior therapies
- Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities
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 |
|---|---|---|
| Stereotactic Radiosurgery (15 Gy)Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy | Radiation | Stereotactic Radiosurgery (15 Gy) |
| Stereotactic Radiosurgery (12 Gy)Group B will start at Dose Level I: 12 Gy | Radiation | Stereotactic Radiosurgery (12Gy) |
Primary outcome
maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis
Time frame: one year
The maximum tolerated dose (MTD) is defined as the highest dose of stereotactic radiosurgery delivered pre-operative at which no more than 2 out of 6 patients experience a dose limiting toxicity (DLT).
4 secondary outcomes
Acute Toxicity with preoperative stereotactic radiosurgery (SRS)
Time frame: 6 months
Late Toxicity with preoperative stereotactic radiosurgery (SRS)
Time frame: 1 year
Rates of Local Control
Time frame: 2 years
Rates of Leptomeningeal Dissemination
Time frame: 2 years
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 14 May 2018.
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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.
John B. Fiveash, MD principal investigator
Hazelrig-Salter Radiation Oncology Center (HSROC)/ University of Alabama at Birmingham (UAB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiosurgery (15 Gy) and Stereotactic Radiosurgery (12 Gy) in people with Brain Metastases, run by University of Alabama at Birmingham 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 7 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 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis (time frame: one 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 May 2018.