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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.

Stereotactic Body Radiotherapy

Amol J. Ghia, MD

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.

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.

Evaluation of Single Session Stereotactic Body Radiotherapy

Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases

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.

M.D. Anderson Cancer Center

Neoplasms, Second Primary

Neoplastic Processes

Cohort 1: Patients with spinal metastases and no prior radiation Cohort 2: Patients with spinal metastases in a previously radiated field Cohort 3: Post-operative patients with spinal metastases

One or more high dose(s) of radiation to treat the tumour.

Stereotactic Body Radiotherapy (SBRT)

John Cho, MD

Patients with new or recurrent spine metastases are currently treated with low doses of radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely to the metastases to be treated are administered in a small number of sessions, thus reducing the radiation damage to the surrounding tissue and areas of the spine.

The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to conventional radiation for patients with no prior radiation, prior radiation, and in the post-operative patient

Spine SBRT is currently being practiced as an alternative to conventional wide-field radiation in the up-front management of spinal metastases, in the re-irradiation scenario, and in the post-operative setting. This study proposes to treat patients with a uniform spine SBRT approach, and collect prospective outcome data as a basis for future randomized trial design. Preliminary evaluation of our technique has yielded acceptable accuracy in treatment delivery as compared to the literature, and our practice follows current standards in major university hospitals performing this technique. Furthermore, preliminary data also suggest efficacy and safety for patients treated with SBRT for spinal metastases in a previously radiated field. However, well defined prospective outcomes are lacking in this patient group.

There a 3 cohorts for this study each with a target accrual of 30 patients. Cohort 1: patients with spinal metastases and no prior radiation.

Cohort 2: patients with spinal metastases with a history of previous radiation to the affected spinal segment.

Cohort 3: post-operative patients with spinal metastases with or without a history of previous radiation to the affected spinal segment.

All patients will be treated with either 20-24 Gy in one fraction (recommended) or 20-24 Gy in two fractions, or 20-24 Gy in three fractions. There is also and optional imaging component of this study.

The purpose of the study is to determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Single Session Stereotactic Body Radiotherapy	NCT00492817	Spinal Neoplasm...	Stereotactic Bo...	-	M.D. Anderson Cancer Center
Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)	NCT01290562	Spinal Metastas...	Stereotactic Bo...	19 Years -	University Health Network, Toronto
Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)	NCT01290562	Spinal Metastas...	Stereotactic Bo...	19 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for paraspinal metastases