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Stereocord: Stereotactic Radiosurgery in Metastatic Spinal Cord Compression

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Terminated
CT.gov ID
NCT02167633
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
26.1
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of Stereotactic Radiosurgery Versus Decompressive Surgery Followed by Postoperative Radiotherapy in Metastatic Spinal Cord Compression
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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

    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

    • 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ability to walk [6 weeks]

      Ability to walk determined by EQ-5D-5L

    Secondary Outcome Measures

    1. Self reported pain [0, 6, 12, 26, 52 weeks]

      self reported pain determined by EQ-5D-5L

    2. Self reported bladder control [0, 6, 12, 26, 52 weeks]

      reported by questionnaire

    3. Quality of life [0, 6, 12, 26, 52]

      QOL determined by EQ-5D-5L

    4. Response rate [6 weeks]

      Post interventional MRI scan with response classified according to RECIST 1.1

    5. Toxicity and interventional related complications [0, 6, 12, 26, 52 weeks]

      Determined by CTCAE 4.0

    Other Outcome Measures

    1. Days of treatment [52 weeks]

      measurement of therapy related treatment days both as ambulatory and admitted to the hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark 2100

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Morten Hiul Suppli, MD, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT02167633
    Other Study ID Numbers:
    • H-3-2014-050
    • RH SRS in MESCC 2014
    First Posted:
    Jun 19, 2014
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Morten Hiul Suppli, MD, Rigshospitalet, Denmark
    Radiosurgery
    Laminectomy
    Radiotherapy
    Spinal Cord Compression
    Neoplasm Metastasis
    Randomized Controlled Trial
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Spinal Cord Compression
    Pantoprazole
    Proton Pump Inhibitors
    Glucocorticoids

    Study Results

    No Results Posted as of Mar 11, 2021