Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

NCT00855803 | Completed Phase 2 Results DMC

• 1 other identifier: STU 072010-134
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis. PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.

Conditions

Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

spinal cord metastases; unspecified adult solid tumor, protocol specific; pain

Outcome Measures

Primary Outcomes (1)

• Pain Response as Measured by VAS at 3 Months

  Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response

  3 month

Secondary Outcomes (4)

• Pain Response

  1 month

• Overall Survival

  5 year

• Daily Function

  Baseline

• Quality of Life Questionnaire Responses

  12 months

Study Arms (1)

Radiation followed by Vertebroplasty

EXPERIMENTAL

Intervention: This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty\*. \*Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up.

Radiation: radiation

Interventions

radiation RADIATION

Given in 1 or 5 fractions

Also known as: stereotactic body radiation therapy

Radiation followed by Vertebroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
• Patients must have a VAS of ≥4 at any of the planned treatment sites
• Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
• Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
• Narcotic pain prescription and usage information must be available and documented
• Patients must sign study specific consent
• Above the age of 18
• For women of childbearing age a negative pregnancy test is required
• Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
• Zubrod score of 0-2

You may not qualify if:

• Patients who have been non-ambulatory for more than 7 days
• Patients with compression fractures
• Spine instability requiring fixation
• Patients with paraspinal extension
• Patients with bony fragments
• Planned systemic treatment within one week after treatment.
• Absence of pathological diagnosis of cancer
• Chemotherapy within one week of treatment
• Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
• Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Patient had a transmural myocardial infarction within the last 6 months
• Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
• PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pain

Interventions

Radiation; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Robert Timmerman
• Organization: University of Texas Southwestern Medical Center

robert.timmerman@utsouthwestern.edu

214/645-7637

Study Officials

• Robert D. Timmerman, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: February 1, 2009
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: March 16, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)