Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression

NCT01256554 | Completed Phase 1

• 2 other identifiers: 2010-0653NCI-2011-00273
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.

Conditions

Metastatic Epidural Spinal Cord Compression

Keywords

Stereotactic Radiosurgery; SSRS; Radiation; Radiotherapy; Metastatic Epidural Spinal Cord Compression; MESCC

Outcome Measures

Primary Outcomes (1)

• Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)

  Maximum acceptable Dmax will be that in which there are fewer RM events than TP events prior to 12 months and less than 2 RM events.

  Up to 12 months following radiation

Study Arms (1)

Stereotactic Radiosurgery (SSRS)

EXPERIMENTAL

Target dose of 18 or 24 Gy to spine in single session of radiation. Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.

Procedure: Stereotactic Radiosurgery (SSRS); Behavioral: Questionnaires

Interventions

Stereotactic Radiosurgery (SSRS) PROCEDURE

Target dose of 18 or 24 Gy to spine in single session of radiation.

Also known as: Stereotactic Radiosurgery, SSRS, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC

Stereotactic Radiosurgery (SSRS)

Questionnaires BEHAVIORAL

Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.

Also known as: Surveys

Stereotactic Radiosurgery (SSRS)

Eligibility Criteria

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

You may qualify if:

• Greater than or equal to 18 years old
• Radiographically documented metastatic epidural compression on spine Magnetic resonance imaging (MRI) within 4 weeks of registration, defined radiographically, ranging from minimal canal compromise and thecal indentation to actual displacement of the spinal cord.
• Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
• Signed Informed consent for irradiation
• Diagnosis of cancer including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
• Motor Strength \>/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
• Karnofsky performance status (KPS) \>/= 40
• Patients deemed to be inoperable due to patient refusal, by neurosurgical evaluation, or for any reason
• prior course of spine radiotherapy to the current region of interest

You may not qualify if:

• Prior irradiation of the site to be treated \</= 3 months prior to registration
• Inability to tolerate lying flat on treatment table for greater than 30 minutes.
• Patients unable to undergo MRI of the spine
• Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or similar biologically effective dose (BED) to the area of the spine to be treated. Below are the normalized BED at 2 Gy per fraction with alpha/beta=2 for spinal cord in commonly used fractionation schemes in previously irradiated patients. Conventional Radiotherapy (Normalized Biologically Effective Dose) 20 Gy in 5 fractions(30 Gy 2/2), 30 Gy in 10 fractions(37.5 Gy 2/2), 37.5 Gy in 15 fractions(42 Gy 2/2), 40 Gy in 20 fractions(40 Gy 2/2), 45 Gy in 25 fractions(43 Gy 2/2), 50 Gy in 25 fractions(50 Gy 2/2) following equation: nBED is calculated by dividing BED by (1 + d/a/b), where d is 2 Gy and for spinal cord late effect a/b is 2, and we describe the units as Gy 2/2 (i.e., Gy 2/2 = 2-Gy equivalent with a/b = 2)
• Patients who are pregnant.
• Patients who have cord compression from bone components or configuration

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Radiosurgery; Radiation; Radiotherapy; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Physical Phenomena; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amol J. Ghia, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: December 3, 2010
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

US (1)