MDACC Study Summary 2005-0445

Study Summary
No. 2005-0445:.......Breast; Gastrointestinal; Genitourinary; Lung; Lymphoma; Melanoma; Sarcoma; Spinal......Eric L. Chang......Radiation Oncology

Study Summary Title



Study Summary Number:	2005-0445

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

Physician

New Patient Referral



Name:	Eric L. Chang	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:	N/A

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 body radiotherapy to the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment of metastatic spine tumors.

Study Objectives / Outcomes

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

Study Status Information



Study Activation / Registration Date:	10/13/2005

IRB Review and Approval Date:	08/17/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

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 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

Links

Registration Number: NCT00492817
Study Information on Clinical Trials Registry (clinicaltrials.gov)