Trial Title:
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
NCT ID:
NCT06613295
Condition:
Solid Tumor
Spinal Neoplasms
Spinal Tumor
Conditions: Official terms:
Spinal Cord Neoplasms
Spinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SABR
Description:
SABR
Arm group label:
Separation surgery followed by stereotactic ablative body radiotherapy
Arm group label:
Stereotactic ablative body radiotherapy
Intervention type:
Procedure
Intervention name:
Separation surgery
Description:
Separation surgery
Arm group label:
Separation surgery followed by stereotactic ablative body radiotherapy
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.
Detailed description:
In this study, patients with malignant epidural spinal cord compression (MESCC), Bilsky
grade 1c, 2 and 3 who are ambulatory with or without aid (rollator, cane, one persons
help) will be treated by separation surgery followed by SABR (5x 8.0 Gy postoperative)
(control arm) or SABR alone (5x 8.0 Gy) (study arm). The primary objective of the study
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.
For each participant, the study starts once written informed consent is provided and is
composed by 4 study phases: a screening phase, randomisation, a treatment phase and a
follow-up phase.
The screening phase will allow for assessment of subject eligibility before randomisation
and treatment. Demographic data, disease and spinal metastases characteristics and
previous anticancer therapies will be recorded. Once all screening procedures are
completed, eligibility will be determined according to the inclusion/exclusion criteria.
Randomisation will be performed in a 1:1 ratio to the control arm (separation surgery
followed by SABR) and the study arm (SABR) using an electronic randomisation tool in the
eCRF.
Treatment will be aimed to start as soon as possible, but certainly within 21 days after
randomisation (surgery or upfront SABR). Surgical planning is done by the treating
neurosurgeon in the participating center where the patient was included. 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.
At 6 weeks (+/-1 week) after the last RT session following information will be obtained
(preferentially by digital consult):
1. Ambulatory status 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
2. WHO performance status
3. Acute and late toxicity assessment: as measured with CTCAE version 5.0
4. Need for re-intervention, date and type of reintervention (surgery or radiotherapy),
reason (wound infection, neurologic decline, loss of ability to walk or other)
5. Pain response: VAS pain score
6. Survival data (survival status, date of death, primary cause of death)
At 3 and 6 months (+/-3 weeks) after the last RT session following information will be
obtained by physical or digital consult:
1. Ambulatory status 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
2. WHO performance status
3. Concomitant medications and systemic anticancer therapies
4. QoL according to the EORTC QLQ-C15 & BM22 questionnaires
5. Acute and late toxicity assessment: as measured with CTCAE version 5.0
7. Need for re-intervention, date and type of reintervention (surgery or radiotherapy),
reason (wound infection, neurologic decline, loss of ability to walk or other) 6.
Pain response: VAS pain score 7. Physical examination: body weight 8. Local control
9. Survival data (survival status, date of death, primary cause of death)
At 12 and 24 months (+/-3 weeks) after the last RT session following information will be
obtained (preferentially by digital consult):
1. Ambulatory status 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
2. Need for re-intervention, type of reintervention
3. Survival data (survival status, date of death, primary cause of death)
4. Local control (only if information is available in medical record as per standard of
care)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OLVZ Aalst
Address:
City:
Aalst
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Samuel Bral, MD
Phone:
053728656
Phone ext:
32
Email:
samuel.bral@olvz-aalst.be
Contact backup:
Last name:
Samuel Bral
Facility:
Name:
AZ Klina
Address:
City:
Brasschaat
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Ruben Van Den Brande, MD
Phone:
036505092
Phone ext:
32
Email:
ruben.vandenbrande@azklina.be
Contact backup:
Last name:
Ruben Van Den Brande
Facility:
Name:
UZA
Address:
City:
Edegem
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Marika Rasschaert, MD
Phone:
038212441
Phone ext:
32
Email:
marika.rasschaert@uza.be
Contact backup:
Last name:
Marika Rasschaert
Facility:
Name:
ZOL
Address:
City:
Genk
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Evelyn Van de Werf, MD
Phone:
011337918
Phone ext:
32
Email:
evelyn.vandewerf@zol.be
Contact backup:
Last name:
Evelyn Van de Werf
Facility:
Name:
Jessa
Address:
City:
Hasselt
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Katleen Verboven, MD
Phone:
011337918
Phone ext:
32
Email:
katleen.verboven@jessazh.be
Contact backup:
Last name:
Katleen Verb
Facility:
Name:
AZ Groeninge
Address:
City:
Kortrijk
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Isabelle Kindts, MD
Phone:
056633943
Phone ext:
32
Email:
isabelle.kindts@azgroeninge.be
Contact backup:
Last name:
Isabelle Kindts
Facility:
Name:
AZ Sint-Maarten
Address:
City:
Mechelen
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Julie van der Veen, MD
Phone:
015891664
Phone ext:
32
Email:
julie.van.der.veen@emmaus.be
Contact backup:
Last name:
Julie van der Veen
Facility:
Name:
VITAZ
Address:
City:
Sint-Niklaas
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Erik Van de Kelft, MD
Phone:
037607565
Phone ext:
32
Email:
erik.vandekelft@vitaz.be
Contact backup:
Last name:
Erik Van de Kelft
Facility:
Name:
GZA
Address:
City:
Wilrijk
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Charlotte Billiet, MD
Phone:
034433759
Phone ext:
32
Email:
charlotte.billiet@gza.be
Contact backup:
Last name:
Charlotte Billiet
Start date:
March 7, 2022
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Cancer Research Antwerp
Agency class:
Other
Source:
Cancer Research Antwerp
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613295
