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

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Spine Radiosurgery

Magnetic Resonance imaging

MR-LINAC

About this trial

This is an interventional treatment trial for Spinal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Age ≥ 18 years old Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed) Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed Diagnosis of cancer documented Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3 EXCLUSION CRITERIA: Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc) Patients who are unable to undergo MRI of the spine with contrast Patients who are pregnant

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1 (Therapeutic Cohort)

Group 2 (Imaging-only Cohort)

Arm Description

Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05709782

First Posted

January 24, 2023

Last Updated

May 10, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05709782

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 9, 2023 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (Therapeutic Cohort)

Arm Type

Experimental

Arm Description

Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

Arm Title

Group 2 (Imaging-only Cohort)

Arm Type

Experimental

Arm Description

Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.

Intervention Type

Procedure

Intervention Name(s)

Spine Radiosurgery

Intervention Description

scan

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance imaging

Intervention Description

scan

Intervention Type

Radiation

Intervention Name(s)

MR-LINAC

Intervention Description

scan

Primary Outcome Measure Information:

Title

M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires

Description

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.

Time Frame

through study completion; an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

INCLUSION CRITERIA: Age ≥ 18 years old Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed) Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed Diagnosis of cancer documented Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3 EXCLUSION CRITERIA: Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc) Patients who are unable to undergo MRI of the spine with contrast Patients who are pregnant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Debra N. Yeboa, MD

Phone

(713) 563-2415

Email

dnyeboa@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debra N. Yeboa, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Debra Yeboa, MD

Phone

713-563-2415

Email

dnyeboa@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Debra N. Yeboa, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Spinal Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial