Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases

NCT06613295 | Recruiting

• 1 other identifier: CTO21003GZA
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 9

Brief Summary

This is a non-inferiority, randomised controlled trial to investigate the effect of stereotactic ablative body radiotherapy (SABR) compared to separation surgery followed by SABR in ambulatory patients with malignant epidural spinal cord compression (MESCC). The primary objective of the project is investigating the effect of SABR compared to separation surgery followed by SABR in ambulatory patients with MESCC on retaining ambulatory function. The primary endpoint of the study is ambulatory function 3 months post treatment defined as: being able to walk 10m without aid; being able to walk 10m with aid (cane, rollator, one persons help, …); not being able to walk. Secondary outcomes are local control, progression free survival, early and late adverse effects, quality of life, effect on pain and need for reintervention. The aim is to randomise 128 patients 1:1 to either "separation surgery" followed by SABR (5x 8.0 Gy postoperative) (control arm) vs. SABR alone (5x 8.0 Gy) (study arm). Patients will be evaluated at 3 and 6 months after treatment with MRI scan, quality of life questionnaires, anamnestic and clinical evaluation at clinical follow ups for assessment of ambulatory function, acute and late toxicity and need for reintervention. Moreover, at 6 weeks, 12 months and 24 months after treatment a teleconsult for assessment of ambulatory function, and need for reintervention will be performed.

Conditions

Solid Tumor; Spinal Neoplasms; Spinal Tumor

Outcome Measures

Primary Outcomes (1)

• Proportion of ambulant patients at 3 months

  The ambulatory status is scored binary (without or with aid vs not being able to walk)

  3 Months post treatment

Secondary Outcomes (8)

• Local recurrence rate

  Up to 24 months post treatment

• Time to loss of ambulation

  Up to 24 months post treatment

• Progression free survival (PFS)

  Up to 24 months post treatment

• Overall survival

  Up to 24 months post treatment

• Number of patients with re-intervention and time to re-intervention (surgery, RT, …)

  Up to 24 months post treatment

Study Arms (2)

Separation surgery followed by stereotactic ablative body radiotherapy

ACTIVE COMPARATOR

Surgery will take place within 21 days after randomisation. Surgical planning is done by the treating neurosurgeon in the participating center where the patient was included. The goal of separation surgery for intraspinal MESCC is to remove intraspinal epidural disease to allow a margin between the spinal cord (or cauda equina) and the treated radiotherapy volume, and to provide histological diagnosis or confirmation of the metastasis. The decompression should be as minimal invasive as possible, i.e. only intraspinal tumour tissue should be removed, while preserving as much as possible all of surrounding spinal structures. Separation surgery must be followed by SABR after minimum 2 and maximum 4 weeks postoperatively. Image-guided fractionated SABR using a SIB technique to the high-dose PTV will be delivered in 5 fractions of 8 Gy to a total of 40 Gy and to the conventional-dose PTV delivered simultaneously in 5 fractions of 4 Gy to a total of 20 Gy.

Radiation: SABR; Procedure: Separation surgery

Stereotactic ablative body radiotherapy

EXPERIMENTAL

SABR will start within 21 days of randomisation. Image-guided fractionated SABR using a SIB technique to the high-dose PTV will be delivered in 5 fractions of 8 Gy to a total of 40 Gy and to the conventional-dose PTV delivered simultaneously in 5 fractions of 4 Gy to a total of 20 Gy.

Radiation: SABR

Interventions

SABR RADIATION

SABR

Separation surgery followed by stereotactic ablative body radiotherapy; Stereotactic ablative body radiotherapy

Separation surgery PROCEDURE

Separation surgery

Separation surgery followed by stereotactic ablative body radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a solid malignant tumour (preferentially histologically proven;alternatively obtained by spinal surgical procedure)
• Age 18 years or older
• Histological, radiological or scintigraphical evidence of spinal metastasis (no limitation in the number of sites of metastases)
• Spinal instability neoplastic score (SINS) \<13 (i.e. no need for stabilisation of the spine) (see Appendix 6)
• Spinal metastasis with MESCC: ESCC grade 1c, 2 and 3 (see Appendix 7)
• Ambulatory: being able to walk 10m without aid or with aid (cane, rollator, one persons help).
• Life expectancy estimated to be at least 3 months.
• World Health Organization (WHO) Performance Status of 0-2 (some help) (see Appendix 3)
• Patient has given written informed consent.

You may not qualify if:

• Contra indication for MRI scan (e.g. pacemaker)
• Previous RT or surgery at the level of the affected vertebrae
• Non-solid primary tumours (e.g. lymphoma, multiple myeloma, germ cell tumours)
• Non ambulatory at presentation
• More than 3 affected vertebrae in one target site
• More than 2 treatment sites
• SINS ≥ 13 (unstable spine)

Sponsors & Collaborators

• Cancer Research Antwerp: lead

Study Sites (9)

OLVZ Aalst

Aalst, Belgium

NOT YET RECRUITING

AZ Klina

Brasschaat, Belgium

NOT YET RECRUITING

UZA

Edegem, Belgium

NOT YET RECRUITING

ZOL

Genk, Belgium

RECRUITING

Jessa

Hasselt, Belgium

NOT YET RECRUITING

AZ Groeninge

Kortrijk, Belgium

NOT YET RECRUITING

AZ Sint-Maarten

Mechelen, Belgium

NOT YET RECRUITING

VITAZ

Sint-Niklaas, Belgium

RECRUITING

GZA

Wilrijk, Belgium

RECRUITING

MeSH Terms

Conditions

Spinal Neoplasms; Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charlotte Billiet, MD, PhD

  ZAS Augustinus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Billiet, MD, PhD

CONTACT

03234433759; gza.cancertrials@zas.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: September 25, 2024
• Study Start: March 7, 2022
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (9)