Stereotactic Radiosurgery in Metastatic Spinal Cord Compression

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.

Conditions

• Spinal Cord Compression
• Neoplasm Metastasis

Interventions

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

Sponsors & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Morten H Suppli, MD · Rigshospitalet, Denmark

• Svend Aage Engelholm, MD · Rigshospitalet, Denmark

• Benny Dahl, MD · Rigshospitalet, Denmark

• Helle Pappot, MD · Rigshospitalet, Denmark

• Per Munck af Rosenschöld, Medical Physicist · Rigshospitalet, Denmark

• Søren S Morgen, MD · Rigshospitalet, Denmark

• Ivan Vogelius, Medicial Physicist · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• Denmark

Study Locations