Stereotactic Radiosurgery in Metastatic Spinal Cord Compression — Stereocord  

Neoplasm Metastasis Clinical Trial

Official title: A Randomized Trial of Stereotactic Radiosurgery Versus Decompressive Surgery Followed by Postoperative Radiotherapy in Metastatic Spinal Cord Compression

Status Terminated

Clinical Trial Summary

To determine whether stereotactic radiosurgery of metastatic spinal cord compression is equivalent to decompressive surgery followed by external body radiation therapy to maintain ability to walk at 6 weeks.

Clinical Trial Description

Metastatic spinal cord compression (MSCC) is an acute event demanding treatment which otherwise would eventually lead to paraplegia in all patients. This is a serious condition for the individual cancer patient and burdensome for the healthcare system. A surgical intervention plus fractionated radiation therapy (FRT) is currently the standard treatment.

Proposed Solution: If spinal cord dose is respected, local tumor control could be equivalent using stereotactic body radiation therapy (SBRT) with minimal risk in comparison to decompression surgery and postoperative conventional radiotherapy without the additional burden on the patient of performing an invasive surgical procedure.

Clinical Impact:

Patients currently requiring surgery plus radiation therapy will potentially benefit form the proposed method. Patients will potentially benefit from reduced toxicity by avoiding the surgical procedure. In addition, a shorter treatment protocol with only one fraction is beneficial.

Aims:

The investigators' hypothesis is that stereotactic body radiation therapy (SBRT) could be equivalent alternative in the case of patients presenting with metastatic spinal cord compression with minor neurologic deficits.

Specific aims:

1. Determine the feasibility of recruiting patients to be randomized towards SBRT vs. of surgery plus FRT

2. Determine the ability to walk after 6 weeks measured from the starting date of treatment

3. Determine the side-effects and quality of life metrics following both treatment arms

4. Determine the rate of local control following therapy using MRI scan

Project Plan:

The investigators intend to investigate if stereotactic body radiation therapy (SBRT) could be equivalent alternative in the case of patients presenting with metastatic spinal cord compression with minor neurologic deficits ;

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Cord Compression

• NCT number: NCT02167633
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Completion date: September 2016