MDACC Study Summary ID02-446

Study Summary
No. ID02-446:.......Breast; Gastrointestinal; Genitourinary; Lung; Lymphoma; Melanoma; Sarcoma; Spinal......Paul Brown......Radiation Oncology

Study Summary Title



Study Summary Number:	ID02-446

Study Title:	Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease

Physician

New Patient Referral



Name:	Paul Brown	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Breast Gastrointestinal Genitourinary Lung Lymphoma Melanoma Sarcoma Spinal	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Patients will be seen 1x/wk during xrt and will have a telephone, fax, or mail follow up at 2 wks, 4wks, and 2 months posr radiation. Pt will be seen for follow up visits at 3, 6, 9, 12, 18, and 24 months and then every six months.

Treatment Agents:	Radiation	Home Care:	none

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.

Study Objectives / Outcomes

1.0 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.
1.1 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
1.2 Document changes in neurological function at defined intervals compared to
pre-treatment neurological function
1.3 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

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/04/2002

Study Type:

Recruitment Status:	Closed

Projected Accrual:	150

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, germ cell tumors, and unknown primary tumors

5) Karnfosky 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.

Links

Registration Number: NCT00508443
Study Information on Clinical Trials Registry (clinicaltrials.gov)