Evaluation of Single Session Stereotactic Body Radiotherapy

• ClinicalTrials.gov Identifier: NCT00492817
• Recruitment Status: Active, not recruiting
• First Posted: June 27, 2007
• Last Update Posted: December 2, 2020
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Neoplasms	Procedure: Stereotactic Body Radiotherapy	Phase 1; Phase 2

Detailed Description:

CT-on-Rails is a system that places the radiation treatment machine in the same room as the CT scanner so that the CT scanner can help deliver radiation more precisely.

You will have a MRI of the spine within 1 month before registration on this study. You will also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week before registration. Each of these surveys should take about 5 minutes to complete. You will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep you from moving during scanning and later radiation treatment. However, no radiation is delivered during the simulation. You will be asked questions about your medical history and have a complete neurological exam during your first consultation, before registration. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.

Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1 to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic wrap) placed around you that will hold you still during the treatment. You will be checked for level of pain and/or discomfort before starting each session of radiation, and you may take pain medications before starting each session. All participants will be treated with radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment.

During treatment, a physician will be monitoring you for any side effects. If you experience severe side effects, radiation treatment will be stopped, and you will be taken off study. After treatment on this study ends, you will have telephone, mail, or facsimile (Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked questions about any side effects or pain you are experiencing and any other therapies you may have started.

You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6 months for the rest of your life. At all follow-up visits, you will be asked questions about your medical history, have a neurological exam, and your neurologic function will be evaluated. Any pain medication you are taking will be noted. You will be asked to have a MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your life. You will also be asked to complete 3 questionnaires to evaluate your symptoms, pain, and quality of life at each follow-up visit. Each questionnaire should take around 5 minutes to complete.

This is an investigational study. The equipment used in this study are FDA-approved medical devices and are commercially available. However, the way the devices are being used in this study is experimental. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases
• Actual Study Start Date: October 2005
• Estimated Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: October 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single Session Stereotactic Body Radiotherapy (SBRT); 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; 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.; Other Name: SBRT

Outcome Measures

Primary Outcome Measures :

1. Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and para-Spinal Tumors in a Single Session [ Time Frame: 3 months ]
   The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief will be the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 weeks of registration
2. Maximum of 2 metastatic sites in the spine to be irradiated in single session
3. Informed consent for irradiation of spinal or para-spinal tumor (s)
4. 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
5. Karnofsky performance status of at least 40 (ie not requiring active hospitalization)

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Amol J. Ghia, MD; M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00492817
• Other Study ID Numbers: 2005-0445; NCI-2012-01499 ( Registry Identifier: NCI CTRP )
• First Posted: June 27, 2007
• Last Update Posted: December 2, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

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