Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

Spinal Disease Clinical Trial

Official title:

Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709782
• Other study ID #: 2022-0589
• Secondary ID: NCI-2023-00663
• Status: Recruiting
• Phase: Phase 2
• Start date: May 9, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Debra N. Yeboa, MD
• Phone: (713) 563-2415
• Email: dnyeboa[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

Description:

Primary objective:

• To determine the 6-month local control (LC) of the target site of treatment.

Secondary Objectives:

• To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)

• To determine the 1-year local control of the target site

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

1. Age = 18 years old

2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)

3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review

4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed

5. Diagnosis of cancer documented

6. Motor strength = 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation

7. Karnofsky Performance score (KPS) = 40 or ECOG score = 3

EXCLUSION CRITERIA:

1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)

2. Patients who are unable to undergo MRI of the spine with contrast

3. Patients who are pregnant

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases

Intervention

Procedure:
• Spine Radiosurgery
scan

Device:
• Magnetic Resonance imaging
scan

Radiation:
• MR-LINAC
scan

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires	M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be) for each item.	through study completion; an average of 1 year

External Links

•   M D Anderson Cancer Center