An interventional study of SABR and Separation surgery in Solid Tumor, Spinal Neoplasms and Spinal Tumor, sponsored by Cancer Research Antwerp. Recruiting at 9 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Cancer Research Antwerp · Not applicable, Interventional, and Treatment
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.
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):
At 3 and 6 months (+/-3 weeks) after the last RT session following information will be obtained by physical or digital consult:
At 12 and 24 months (+/-3 weeks) after the last RT session following information will be obtained (preferentially by digital consult):
18 studies on the registry are indexed under Spinal Neoplasms; 5 are open to participants now.
This study's planned enrollment of 128 is above the median of 71 across 11 interventional studies indexed under Spinal Neoplasms.
Browse Spinal Neoplasms studies →Cancer Research Antwerp is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
SABR
Separation surgery
Proportion of ambulant patients at 3 months
The ambulatory status is scored binary (without or with aid vs not being able to walk)
Time frame: 3 Months post treatment
Local recurrence rate
Time between date of study registration and date of local recurrence
Time frame: Up to 24 months post treatment
Time to loss of ambulation
Time between date of study registration and date of loss of ambulation (in days)
Time frame: Up to 24 months post treatment
Progression free survival (PFS)
Time between date of study registration and date of local recurrence
Time frame: Up to 24 months post treatment
Overall survival
Time between date of study registration and date of death of any cause or last follow-up
Time frame: Up to 24 months post treatment
Number of patients with re-intervention and time to re-intervention (surgery, RT, …)
Time between date of treatment and date of re-intervention
Time frame: Up to 24 months post treatment
Acute and late toxicity
Incidence of Adverse Events as assessed by the CTCAE version 5.0
Time frame: Up to 6 months post treatment
Quality of life measurement by QLQ-BM22 and QLQ-C15-PAL questionnaires
Difference in QLQ-BM22 and QLQ-C15-PAL scale scores
Time frame: Up to 6 months post treatment
Pain response (VAS score)
Improvement by ≥ 2 points on the pain (VAS score) at the treatment site
Time frame: Up to 6 months post treatment
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Mar 2025, 35 months after the start.
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Cancer Research Antwerp