Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Second radiation for spine tumors: safe or risky?

NCT ID NCT02278744

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested whether giving a second, single dose of highly focused radiation is safe for people with spine tumors that have grown back after previous radiation. Nine adults with certain types of cancer took part. The goal was to find the highest safe dose and watch for side effects within the first year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Oct 2014

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Target lesion size for re-irradiation must be ≤ 2 vertebral bodies * KPS ≥ 60% * Age ≥ 18 years old Exclusion Criteria: * 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 * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic spine lesions are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States