NCT02167633

Stereotactic Radiosurgery in Metastatic Spinal Cord Compression

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Spinal Cord Compression
• Neoplasm Metastasis

Interventions

Type	Name	Description
PROCEDURE	Decompression surgery	Patients will undergo posterior decompression/laminectomy on relevant spinal levels depending on neurological symptoms. If there is a need of spinal stabilization after decompression, patients will undergo posterior instrumentation with pedicle screws and titanium rods. Instrumentation will be done two or three levels above and below each level with metastatic affection.
RADIATION	Radiosurgery	Patients treated with radiosurgery/SBRT will receive a prescribed dose of 16 Gy in 1 fraction to cover as large a fraction as possible the defined target volume
RADIATION	Fractionated Radiotherapy	Patients allocated to surgery will receive postoperative radiotherapy commencing between 10 to 21 days after decompressive surgery. Target should include the entire vertebral body and the vertebral arch at the operated level of the vertebral column. Patients receiving postoperative radiotherapy will receive 30 Gy in 10 fractions with 3 Gy pr. fraction. The prescribed dose should cover at least 90 % of the defined target volume.
DRUG	Glucocorticoids	All patients referred with clinical suspicion of metastatic spinal cord compression will receive high dose glucocorticoids. Dose adjusted to risc of side effects.
DRUG	Pantoprazole	All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-06-19
• Last updated: 2021-03-11

Locations

1 site across 1 country: Denmark