Evaluation of Single Session Stereotactic Body Radiotherapy

NCT00492817 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 2005-0445NCI-2012-01499
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment of metastatic spine tumors. Objectives:

• Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to treat spine and para-spinal tumors in a single session.
• Document frequency and severity of pain, symptoms and symptom interference, as well as quality of life before and after treatment.
• Document changes in neurological function at defined intervals compared to pre-treatment neurological function.

Conditions

Spinal Neoplasms

Keywords

Spinal Neoplasms; Paraspinal Metastases; Stereotactic Body Radiotherapy; CT-on-Rails; Spinal Cord; SBRT

Outcome Measures

Primary Outcomes (3)

• Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session

  To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero

  Six months after completion of radiation therapy

• Local Tumor Control Rate

  Local tumor control rate as measured based on spinal MRI showing absence of progression

  local tumor control rate, the time frame is up to 48 months

• Paralysis (Grade 4 Motor Neuropathy)

  Evidence of paralysis (Grade 4 motor neuropathy) casued by radiation myelitis

  Up to 24 months after radiation therapy

Study Arms (1)

Single Session Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.

Procedure: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy PROCEDURE

On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.

Also known as: SBRT

Single Session Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 weeks of registration
• Maximum of 2 metastatic sites in the spine to be irradiated in single session
• Informed consent for irradiation of spinal or para-spinal tumor (s)
• Diagnosis of cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell tumors, unknown primary tumors
• Karnofsky performance status of at least 40 (ie not requiring active hospitalization)

You may not qualify if:

• Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy.
• Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome
• Prior irradiation to current site of interest in the spine
• Spinal metastasis in the cervical spine are not eligible for treatment
• Unstable spine requiring surgical stabilization.
• Sites outside the spine (eg. lung, liver) are not eligible for treatment
• Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
• Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
• Patient with multiple myeloma
• Patients unable to undergo MRI of the spine
• Patients with pacemakers

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Spinal Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Amol J. Ghia, MD
• Organization: The University of Texas MD Anderson Cancer Center

ajghia@mdanderson.org

(832) 628-7357

Study Officials

• Amol J. Ghia, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: October 13, 2005
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-10

Locations

US (1)