Risk Adapted Spinal Cord/Cauda Constraint Relaxation for... | NCT06204315

ID	Type	Description	Link
NCI-2024-00049	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2024Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 3, 2024

First Posted Date

Jan 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Name	Class
Brainlab AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

Detailed Description

Primary Objectives The primary protocol objectives are to establish the safety of CDE-SSRS alone in participants with MESCC. Specifically, we aim to maintain an RM risk no greater than 1%. RM will be defined as non-functional paresis per the McCormick score (i.e., Grade D).

Secondary Objectives Secondary objectives include pain control as measured by the Brief Pain Inventory, quality of life as measured by the EQ-5D, symptom burden as measured by the MDASI-SP, overall survival, toxicity, ambulatory rate and cost-effectiveness. LC will be defined radiographically with serial MRI scans by the study radiologist per SPINO criteria.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stereotactic Radiosurgery	Experimental	A non-invasive, non-surgical procedure that precisely delivers radiation to cancer on the spine while avoiding surrounding, healthy tissue.	Radiation: Stereotactic Radiosurgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stereotactic Radiosurgery	Radiation	Given by RTx	Stereotactic Radiosurgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and adverse events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Greater than or equal to 18 years old
Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.
Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
All participants must have a vertebral level site of interest from C1 to S2
Signed informed consent
Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
ECOG ≤ 2

Exclusion Criteria:

Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
Prior history of radiation at the spinal site of interest
Inability to lie supine comfortably for ≥ 60 minutes
Progressive neurological deficits due to compression
Inability of obtain an MRI
Inability or refusal to undergo an MR simulation
No eligible for single fraction SSRS for any reason
Participants who are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques