Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous SystemPhase 2NCT03028337
Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases
A Phase 2 study testing Spine Radiosurgery and Questionnaires in people with Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses. Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
- What is being tested?
- Spine Radiosurgery and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 30 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
- Age >/=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status </=2 (Karnofsky >/=60%)
- Life expectancy of greater than 6 months
- All patients must be able to lie supine
- All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
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- All patients must have radiographic evidence of progression at a spinal site previously irradiated greater than 6 months prior to randomization. This includes indirect radiation exposure to spinal site.
- All patients must have received prior conventional external-beam radiation therapy (cEBRT) to the site of interest to no more than a critical neural tissue dose equivalent dose (EQD)2/2 of 42 Gy in a single session or 50 Gy cumulative over multiple sessions and cauda equina dose EQD2/2 of 50 Gy in a single session or 60 Gy cumulative over multiple session. EQD2/2 is calculated as follows: EQD2/2= biologically effective dose (BED)/(1+d/alpha beta)) where BED=nd(1+d/(alpha beta)) and n=number of fractions, d=dose per fraction and alpha beta ratio of 2.
- All patients must have a vertebral body site to be treated located from T1 to L5
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent is the one approved by MD Anderson IRB.
- Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
- Both men and women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patients unable to undergo magnetic resonance imaging (MRI) of the spine
- Prior radiation at the site of interest within 6 months
- Prior history of radiation at the site of interest resulting in a critical neural tissue dose of EQD2/2 of >42 Gy in a single session
- Patients unable to lie flat comfortably for 2 hours
- Pregnancy status will be obtained at time of consent as is routine for all radiation patients. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects
- Patients with a histology of lymphoma and myeloma histologies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial
The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.
Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.
Read the detailed description
Study Groups:
Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If participant is in Group 1, they will receive spine radiosurgery in a single large dose.
- If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses, which is standard.
Length of Study Participation:
Participant may continue taking part in the study as the doctor thinks it is in their best interest. Participant will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Participation on the study will be over after participant's last follow-up visit.
Radiosurgery:
Participant will have spine radiosurgery in either 1 or 3 treatments as described above.
Participant will sign a separate consent for the surgery that explains the procedure and the risks.
Study Visits:
After surgery, at Months 3,6,9,12,18, and 24 and then every 6 months after that:
- Participant will have a physical exam, including a neurological exam (tests to check the functioning of their nerves, including tests of their strength and sensation.
- Participant will complete the same questionnaires they completed at the beginning of the study.
- Participant will have an MRI.
This is an investigational study. Delivering spine radiosurgery in a single large dose rather than over three smaller doses is considered investigational.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
- Being tested
- Spine Radiosurgery, Questionnaires
- Keywords
- Malignant neoplasms of eye brain and other parts of central nervous system, Solid tumor malignancy, Radiographic evidence of spine metastasis, Spine radiosurgery, Radiation therapy, Radiotherapy, Questionnaires, Surveys, XRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine RadiosurgeryRadiation
Also called Radiotherapy, XRT
Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively.
Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction).
QuestionnairesBehavioural
Also called Surveys
Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires.
Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up.
| Study group | Role | What they receive |
|---|---|---|
| Spine Radiosurgery - 1 Dose | Experimental | Participants receive spine radiosurgery in a single large dose. Receives: Radiation: Spine Radiosurgery; Behavioral: Questionnaires |
| Spine Radiosurgery - 3 Doses | Active comparator | Participants receive spine radiosurgery over 3 smaller doses. Receives: Radiation: Spine Radiosurgery; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.
Measured: 12 months
Secondary outcomes (1)
Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Pain relief assessed by items on the Brief Pain Inventory (BPI) that measure severity, location, and degree of relief due to therapy by use of narcotic and non-narcotic pain medications and steroids. Patients experiencing a decrease of 2 points in the worst pain score for 2 consecutive assessment visits considered to have "partial pain relief". Complete pain relief defined as an average pain score of 0 for 2 consecutive assessment visits.
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 posted23 Jan 2017 (estimated)
- Study start18 Jan 2017
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amol J. Ghia, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028337
- Sponsor's protocol ID
- 2016-0728
- Other IDs
- NCI-2017-00606
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03028337
- Acronym / sponsor ID
- 2016-0728
- Keywords
- Malignant neoplasms of eye brain and other parts of central nervous system, Solid tumor malignancy, Radiographic evidence of spine metastasis, Spine radiosurgery, Radiation therapy, Radiotherapy, Questionnaires, Surveys
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 23 Jan 2017 (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.
The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.
Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.
Detailed description
Study Groups:
Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If participant is in Group 1, they will receive spine radiosurgery in a single large dose.
- If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses, which is standard.
Length of Study Participation:
Participant may continue taking part in the study as the doctor thinks it is in their best interest. Participant will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Participation on the study will be over after participant's last follow-up visit.
Radiosurgery:
Participant will have spine radiosurgery in either 1 or 3 treatments as described above.
Participant will sign a separate consent for the surgery that explains the procedure and the risks.
Study Visits:
After surgery, at Months 3,6,9,12,18, and 24 and then every 6 months after that:
- Participant will have a physical exam, including a neurological exam (tests to check the functioning of their nerves, including tests of their strength and sensation.
- Participant will complete the same questionnaires they completed at the beginning of the study.
- Participant will have an MRI.
This is an investigational study. Delivering spine radiosurgery in a single large dose rather than over three smaller doses is considered investigational.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spine Radiosurgery - 1 Dose | Experimental | Radiation: Spine Radiosurgery, Behavioral: QuestionnairesParticipants receive spine radiosurgery in a single large dose. |
| Spine Radiosurgery - 3 Doses | Active comparator | Radiation: Spine Radiosurgery, Behavioral: QuestionnairesParticipants receive spine radiosurgery over 3 smaller doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
- Age >/=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status </=2 (Karnofsky >/=60%)
- Life expectancy of greater than 6 months
- All patients must be able to lie supine
Key exclusion criteria (6 listed)
- Patients unable to undergo magnetic resonance imaging (MRI) of the spine
- Prior radiation at the site of interest within 6 months
- Prior history of radiation at the site of interest resulting in a critical neural tissue dose of EQD2/2 of >42 Gy in a single session
- Patients unable to lie flat comfortably for 2 hours
- Pregnancy status will be obtained at time of consent as is routine for all radiation patients. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects
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 |
|---|---|---|
| Spine RadiosurgeryAlso: Radiotherapy, XRTSpine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively. Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction). | Radiation | Spine Radiosurgery - 1 Dose, Spine Radiosurgery - 3 Doses |
| QuestionnairesAlso: SurveysParticipants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires. Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up. | Behavioural | Spine Radiosurgery - 1 Dose, Spine Radiosurgery - 3 Doses |
Primary outcome
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Time frame: 12 months
Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.
1 secondary outcome
Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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.
Amol J. Ghia, MD principal investigator
M.D. Anderson Cancer Center
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 Spine Radiosurgery and Questionnaires in people with Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System, run by M.D. Anderson Cancer Center 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 13 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases (time frame: 12 months). 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 2026.