Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613295
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-06
Brief Title:
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy SABR Versus SABR Alone for Spinal Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy Versus Stereotactic Ablative Body Radiotherapy Alone for Spinal Metastases Invading the Spinal Canal a Randomised Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABR-MESCC
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 11 to either separation surgery followed by SABR 5x 80 Gy postoperative control arm vs SABR alone 5x 80 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
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 11 to either separation surgery followed by SABR 5x 80 Gy postoperative control arm vs SABR alone 5x 80 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 80 Gy postoperative control arm or SABR alone 5x 80 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 inclusionexclusion criteria Randomisation will be performed in a 11 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 50
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 50
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
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 inclusionexclusion criteria Randomisation will be performed in a 11 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 50
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 50
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None