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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Supportive care, Treatment Active Not specified Other ID02-446 NCT00508443

Trial Description

Summary

Primary Objectives:

• Establish the safety and feasibility of using a novel CT-on-Rails or Trilogy stereotactic spine radiotherapy system (SSRS) to treat spine and para-spinal tumors and document any toxicity associated with such treatment.

• Document frequency and duration of complete pain relief, partial pain relief, symptoms, symptom interference, and quality of life related to bone metastases in spine and any associated radicular pain caused by nerve root compression

• Document changes in neurological function at defined intervals compared to pre-treatment neurological function

• Establish and quantify the precision and accuracy with which the tumor, spine, spinal cord, and other internal anatomy can be reproduced using a stereotactic body frame

Further Study Information

CT-On-Rails or Trilogy 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 of registration on this study. You will also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief Pain Inventory (5 minutes) within 1 week of registration.

A pretreatment feasibility study will first be performed to determine the precision, accuracy, and reproducibility with which the target volume and critical normal structures (e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this will consist of a CT scan.

Patients will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep the patient from moving during scanning and later treatment.

You will be asked questions about your medical history and have a complete neurological exam during your first consultation. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, mental exam, and way you walk. MRI of the spine must be performed within 1 month of registration. You will be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete, and should be completed within 1 month of being enrolled in the study.

All patients will be treated with radiation therapy that is guided by the CT-on-Rails or Trilogy procedure. Patients will receive a CT scan immediately before the treatment in the same room of the treatment using CT-On-Rails or Trilogy. There will be a total of 3 treatments over a period of 2 weeks.

Monitoring of side effects will be focused on neurological, gastrointestinal, musculoskeletal, and hematological systems. Every attempt will be made to have the patient complete the prescribed course of radiation to maximize the beneficial effect of treatment. However, if there is severe side effects, radiation treatment will be stopped and patients will be taken off study.

You will have follow up visits once a week during radiation treatment, scheduled on the same day as radiation. After treatment, you will have telephone, mail, or follow-ups per fax scheduled at 2 and 4 weeks,and 2 months post radiation. You will have follow up visits scheduled at 3, 6, 9, 12, 18, and 24 months, then every six 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 neurologic function will be evaluated. Any pain medication you are taking will be noted. You will have an 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 and pain. Each questionnaire will take around 5 minutes to complete.

This is an investigational study. The CT-on-rails and Trilogy linear accelerator are FDA-approved medical devices and are commercially available, however, the way these two devices are being used is investigational. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson

Eligibility Criteria

Inclusion Criteria:

1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 wks of registration

2. Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment.

3. Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s)

4. Diagnosis of a primary cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell tumor

5. Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization)

6. Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed.

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. Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment

4. Unstable spine requiring surgical stabilization.

5. Sites outside the spine (eg. lung, liver) are not eligible for treatment

6. Systemic radiotherapy (Sr-89) within 30 days

7. Prior irradiation of the area to be treated within 3 months of registration

8. Patients currently receiving, or who have received chemotherapy within 30 days are not eligible

9. Inability to tolerate lying flat on treatment couch for greater than 30 minutes.

10. Patient with multiple myeloma

11. Patients unable to undergo MRI of the spine

12. Patients with pacemakers

13. Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or equivalent dose to the current area to be treated.

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Eric L. Chang, MD

Principal Investigator

Eric L. Chang, MD

Ph: 713-745-5209

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Eric L. Chang, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00508443
Information obtained from ClinicalTrials.gov on October 15, 2008