JOURNAL ONKOLOGIE – STUDIE

Microsurgical Resection of Intramedullary Spinal Cord Metastases

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06042946

Studienbeginn:
September 2023

Letztes Update:
31.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Spinal Cord Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Cantonal Hospital of St. Gallen

Collaborator:
University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Kantonsspital Aarau, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Klinikum rechts der Isar Technische Universität München, University Hospital Muenster,

Studienleiter

Martin N. Stienen, PD, MD
Principal Investigator
Cantonal Hospital St. Gallen

Kontakt

Martin N. Stienen, PD, MD
Kontakt:
Phone: +41 71 494 2183
E-Mail: martin.stienen@kssg.ch» Kontaktdaten anzeigen

Felix C. Stengel, MD
Kontakt:
Phone: +41 71 494 2184
E-Mail: felix.stengel@kssg.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Cantonal Hospital St. Gallen, Neurosurgery
9000 Saint Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Martin N. Stienen, PD, MD
Phone: +41714942183
E-Mail: martin.stienen@kssg.ch

Felix C. Stengel, MD
Phone: +41714942184
E-Mail: felix.stengel@kssg.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The aim of the study is to establish a multi-center, retrospective database for patients with

intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically

treated ISCM patients.

The hypothesis is that the surgical treatment of selected ISCM patients does not lead to

persistent morbidity and does not increase mortality, compared to patients that are treated

non-operatively.

Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory

status, and overall survival of surgically treated ISCM patients.

The investigators intend to include a control cohort of patients with ISCM from participating

centers, who underwent non-surgical oncological treatment (radiotherapy with or without

chemotherapy). This control cohort of patients will be used to match patients with and

without surgical treatment.

Primary endpoint (analysed in surgically treated ISCM patients):

Functional outcome at 90 days after treatment initiation, measured by the modified McCormick

Scale. This is a score for grading of neurological function in spinal cord conditions.

The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or

quadriplegic). The McCormick scale is suitable for our retrospective study because of its

good reproducibility and comparability.

Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched

patients with and without surgical treatment):

- Functional outcome by the McCormick scale and the modified Japanese Orthopaedic

Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function

of upper and lower extremities, sensory function of upper extremities and sphincter

function / voidance. The mJOA ranges from 0 - 18 points, with higher score values

representing better functional outcome. The minimum clinically important difference of

the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores

lower than 11 indicate severe myelopathy.

- Ambulatory status and continence at 90 days, 6 & 12 months (determined by mJOA

subscores)

- Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)

- Impairment Scale at 90 days, 6 and 12 months

- Rate & type of complications at 90 days after treatment according to The Novel Therapy

- Disability-Neurology Grade (TDN grade)16

- Overall survival (in days)

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Adult patients admitted to one of the participating centres and treated for ISCM

- Available documentation of admission and postoperative status

Exclusion Criteria:

- Patients under the age of 18

Studien-Rationale

Primary outcome:

1. Functional outcome at 90 days after treatment initiation (Time Frame - at 90 days after treatment initiation):
measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Secondary outcome:

1. Functional outcome (Time Frame - at 3, 6 and 12 months after treatment initiation):
modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy

2. Neurological outcome (Time Frame - at 6 and 12 months after treatment initiation):
measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A: Complete. No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing B: Sensory Incomplete. Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body C: Motor Incomplete. Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2) D: Motor Incomplete. Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3 E: Normal. If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits

3. Rate & type of complications (Time Frame - within 90 days after treatment initiation):
Therapy-Disability-Neurology Grade (TDN Grade) Range: Grade 1-5 The Therapy-Disability-Neurology (TDN) grading system is a novel multidimensional classification of complications severity. higher Grades indicate higher severity of complication

4. Functional outcome (Time Frame - at 6 and 12 months after treatment initiation):
measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Studien-Arme

iscm_resection
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy
iscm_radiotherapy
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM

Geprüfte Regime

Microsurgical resection of ISCM:
Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.

Quelle: ClinicalTrials.gov

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