AzTrials
AzTrials

Metastatic Spine LesionsPhase 1NCT02278744

Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery

A Phase 1 study testing single-fraction radiation and MRI and/or CT in people with Metastatic Spine Lesions, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Spine Lesions
What is being tested?
single-fraction radiation and MRI and/or CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
27 Oct 2014to Oct 2027
Phase
Phase 1
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

  • Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by MSKCC pathologic review
  • Patients must have radiographic evidence of malignancy in the spine or cauda equina region (L2 to sacrum) which is suitable for radiation therapy
  • Patients must have received prior external beam radiation therapy to the region proposed for SRS re-irradiation at least 6 months prior to planned re-irradiation
  • For patients who were previously treated at an outside institution, adequate records must be available to determine the true dose the cord/cauda received during prior RT. Sufficiency of the treatment records will be assessed and signed-off by the Medical Physics investigator.
  • Patients must have demonstrated progression of disease on MRI or CT assessment of the spinal cord/cauda within the previous radiation field
  • o progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.
Show all 9Show fewer
  • Target lesion size for re-irradiation must be ≤ 2 vertebral bodies
  • KPS ≥ 60%
  • Age ≥ 18 years old

Who cannot join

  • Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1).
  • Patients with intradural or intramedullary lesions, or lesions with < 2mm distance from tumor to spinal cord
  • Patients with circumferential epidural disease
  • Systemic chemotherapy delivered or planned to be delivered within (+/-) 5 days of SRS re-irradiation
  • Patients receiving bevacizumab within 12 weeks prior to protocol treatment.
  • Unable to undergo either a myelogram or MRI of spinal cord/cauda equina and/or exiting spinal nerves
Show all 17Show fewer
  • Patients who may not receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by the Dose Limit Guidelines Evaluation of doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, kidneys, rectum) will be taken into consideration
  • If repeat irradiation would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
  • If the total prior radiation dose to the spinal cord/cauda equina and/or sacrum over all prior treatments exceeds 100 Gy BED (biologically effective dose), the patient will be ineligible, where a total of 100 Gy BED is determined by the calculation: BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord/cauda/sacrum late effect and equals 2 [Rades 2005, Nieder 2005, Sahgal 2012]
  • Patients with paraspinal extension of disease with visceral involvement exclusive of patients with cauda equina and sacral disease extension.
  • Abnormal complete blood count. Any of the following:
  • Platelet count < 75,K/mcL
  • Hemoglobin level < 9g/dl
  • WBC < 3.5K/mcL
  • Abnormal coagulation profile: INR > 2.5 and/or PTT > 80
  • o Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery

This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Patients will be treated with single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.

Being tested
single-fraction radiation, MRI and/or CT
Keywords
Single-Fraction Stereotactic Radiosurgery, Salvage Re-Irradiation, 14-054

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single-fraction radiationRadiation

    Also called stereotactic radiosurgery (SRS)

    Patients enrolled on this study will be registered into a dose tier and undergo 1 session of image-guided SRS using techniques previously. Three escalating SRS spinal cord/cauda maximum dose (Dmax) levels (14 Gy, 16 Gy, and 17 Gy) will be evaluated to determine the safety of this approach. A minimum of three patients will be treated per dose tier. Toxicity based on NCI CTCAE (v4). Post treatment followup at 2 and 4 months (+/- 2 weeks) post-treatment, at 6 months (+/- 4 weeks) and then every 3 months until 2 years (± 4 weeks). Followup schedule based on last day of treatment. No schedule adjustments based on early or delayed visits.

  • MRI and/or CTDevice

Study groups in NCT02278744
Study groupRoleWhat they receive
single-fraction radiosurgeryExperimentalNot described
Receives: Radiation: single-fraction radiation; Device: MRI and/or CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria

    The toxicities associated with single fraction stereotactic radiosurgery to the spine may be classified as either early (occurring within 90 days of the treatment) or late toxicities (after 90 days to 1 year). These toxicities will be evaluated with the National Cancer Institute (NCI) Common Toxicity Criteria.

    Measured: 1 year

Secondary outcomes (2)

  1. local failure

    tumor control will be defined for this study as the absence of tumor progression at the treated site, where progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.

    Measured: 1 year

  2. overall survival

    will be evaluated from the completion of treatment, and analyzed by the Kaplan-Meier method or cumulative incidence curves. For these outcomes, patients across all dose levels will be combined, and will only be evaluated for a maximum of 2 years on protocol.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2014 (estimated)
  2. Study start27 Oct 2014
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02278744
Sponsor's protocol ID
14-054
Status last verified
Nov 2026
First submitted
27 Oct 2014
Last updated
5 Nov 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing single-fraction radiation and MRI and/or CT in people with Metastatic Spine Lesions, run by Memorial Sloan Kettering 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 9 inclusion and 17 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 5 Nov 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 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?

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?

toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02278744.

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 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in