Stereotactic Radiosurgery in Metastatic Spinal Cord Compression (Stereocord)

March 10, 2021 updated by: Morten Hiul Suppli, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histological or cytological confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
  • Patients must have localized spine metastasis from first cervical to last lumbar vertebra with evidence of radiological SCC (rSCC) on a diagnostic MRI defined as involvement or compression of either the spinal cord or the cauda equina by an epidural mass lesion or metastatic disease causing impingement, indentation or loss of definition of the thecal sac
  • A maximum of two separate sites requiring treatment is allowed with maximum two vertebra pr. site
  • Eligible for surgery defined by technical assessment by surgeon whether surgical decompression is possible with proper stabilization of the spine
  • No medical co-morbidity contradicting anesthesia
  • Patient without former treatment for metastatic spinal cord compression with either decompressive surgery and/or radiation therapy
  • Patient with mild to moderate neurologic signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 on MRC scale
  • Age ≥18 years
  • ECOG performance status ≤2
  • Life expectancy of greater than 3 months
  • The effects of ionizing radiation on the developing human fetus are known to be teratogenic. For this reason women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of radiation therapy administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Histology of myeloma or lymphoma
  • Patients with any spine metastasis that is not planned to be treated per protocol
  • Spine instability due to a compression fracture or impending vertebral compression fracture
  • Patients with rapid neurologic decline within 24 hours
  • Bony retropulsion causing neurologic abnormality
  • Prior radiation to the index spine
  • Patients for whom an MRI of the spine is medically contraindicated
  • Patients allergic to contrast dye used in MRIs
  • Patients who are receiving any other investigational agents
  • Patients with more than two known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Patient with any serious neurologic condition other than MSCC that could confound the diagnosis and interpretation of radiation induced myelopathy
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Decompression surgery plus fractionated radiotherapy
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.
Other Names:
  • laminectomy
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.
Other Names:
  • steroids
Drug: Pantoprazole
All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers
Other Names:
  • Proton pump inhibitor (PPI)
Experimental: Radiosurgery
Patients treated with radiosurgery/SBRT will receive a prescribed dose of 16 Gy in one fraction to cover as large a fraction as possible 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.
Other Names:
  • steroids
Drug: Pantoprazole
All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers
Other Names:
  • Proton pump inhibitor (PPI)
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
Other Names:
  • Stereotactic Body Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to walk
Time Frame: 6 weeks
Ability to walk determined by EQ-5D-5L
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported pain
Time Frame: 0, 6, 12, 26, 52 weeks
self reported pain determined by EQ-5D-5L
0, 6, 12, 26, 52 weeks
Self reported bladder control
Time Frame: 0, 6, 12, 26, 52 weeks
reported by questionnaire
0, 6, 12, 26, 52 weeks
Quality of life
Time Frame: 0, 6, 12, 26, 52
QOL determined by EQ-5D-5L
0, 6, 12, 26, 52
Response rate
Time Frame: 6 weeks
Post interventional MRI scan with response classified according to RECIST 1.1
6 weeks
Toxicity and interventional related complications
Time Frame: 0, 6, 12, 26, 52 weeks
Determined by CTCAE 4.0
0, 6, 12, 26, 52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of treatment
Time Frame: 52 weeks
measurement of therapy related treatment days both as ambulatory and admitted to the hospital
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Morten H Suppli, MD, Rigshospitalet, Denmark
  • Study Director: Svend Aage Engelholm, MD, Rigshospitalet, Denmark
  • Study Chair: Benny Dahl, MD, Rigshospitalet, Denmark
  • Study Chair: Helle Pappot, MD, Rigshospitalet, Denmark
  • Study Chair: Per Munck af Rosenschöld, Medical Physicist, Rigshospitalet, Denmark
  • Study Chair: Søren S Morgen, MD, Rigshospitalet, Denmark
  • Study Chair: Ivan Vogelius, Medicial Physicist, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2014-050
  • RH SRS in MESCC 2014 (Other Identifier: Rigshospitalet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasm Metastasis

Clinical Trials on Decompression surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe