Solid TumorSABR-MESCCNCT06613295
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
A study testing SABR and Separation surgery in people with Solid Tumor and Spinal Neoplasms, run by Cancer Research Antwerp at 9 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Spinal Neoplasms, Spinal Tumor
- What is being tested?
- SABR and Separation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 9 sitesBelgium
- Study dates
- 7 Mar 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Belgium9 sites, 9 recruiting
- Not yet recruiting
OLVZ Aalst
Aalst
Samuel Bral, MD, 053728656 ext. 32, samuel.bral@olvz-aalst.be
Samuel Bral
- Not yet recruiting
AZ Klina
Brasschaat
Ruben Van Den Brande, MD, 036505092 ext. 32, ruben.vandenbrande@azklina.be
Ruben Van Den Brande
- Not yet recruiting
UZA
Edegem
Marika Rasschaert, MD, 038212441 ext. 32, marika.rasschaert@uza.be
Marika Rasschaert
- Recruiting
ZOL
Genk
Evelyn Van de Werf, MD, 011337918 ext. 32, evelyn.vandewerf@zol.be
Evelyn Van de Werf
- Not yet recruiting
Jessa
Hasselt
Katleen Verboven, MD, 011337918 ext. 32, katleen.verboven@jessazh.be
Katleen Verb
- Not yet recruiting
AZ Groeninge
Kortrijk
Isabelle Kindts, MD, 056633943 ext. 32, isabelle.kindts@azgroeninge.be
Isabelle Kindts
- Not yet recruiting
AZ Sint-Maarten
Mechelen
Julie van der Veen, MD, 015891664 ext. 32, julie.van.der.veen@emmaus.be
Julie van der Veen
- Recruiting
VITAZ
Sint-Niklaas
Erik Van de Kelft, MD, 037607565 ext. 32, erik.vandekelft@vitaz.be
Erik Van de Kelft
- Recruiting
GZA
Wilrijk
Charlotte Billiet, MD, 034433759 ext. 32, charlotte.billiet@gza.be
Charlotte Billiet
About this study
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
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.
Read more
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.
Read the 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):
- 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
- WHO performance status
- Acute and late toxicity assessment: as measured with CTCAE version 5.0
- Need for re-intervention, date and type of reintervention (surgery or radiotherapy), reason (wound infection, neurologic decline, loss of ability to walk or other)
- Pain response: VAS pain score
- 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:
- 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
- WHO performance status
- Concomitant medications and systemic anticancer therapies
- QoL according to the EORTC QLQ-C15 \& BM22 questionnaires
- Acute and late toxicity assessment: as measured with CTCAE version 5.0
- 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):
- 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
- Need for re-intervention, type of reintervention
- Survival data (survival status, date of death, primary cause of death)
- Local control (only if information is available in medical record as per standard of care)
- Conditions
- Solid Tumor, Spinal Neoplasms, Spinal Tumor
- Being tested
- SABR, Separation surgery
- Medical subject headings
- Spinal Neoplasms, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABRRadiation
SABR
Separation surgeryProcedure or surgery
Separation surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ambulant patients at 3 months
The ambulatory status is scored binary (without or with aid vs not being able to walk)
Measured: 3 Months post treatment
Secondary outcomes (8)
Local recurrence rate
Time between date of study registration and date of local recurrence
Measured: 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)
Measured: Up to 24 months post treatment
Progression free survival (PFS)
Time between date of study registration and date of local recurrence
Measured: 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
Measured: 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
Measured: Up to 24 months post treatment
Acute and late toxicity
Incidence of Adverse Events as assessed by the CTCAE version 5.0
Measured: 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
Measured: Up to 6 months post treatment
Pain response (VAS score)
Improvement by ≥ 2 points on the pain (VAS score) at the treatment site
Measured: Up to 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start7 Mar 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Billiet, MD, PhD, Principal investigator, ZAS Augustinus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613295
- Sponsor's protocol ID
- CTO21003GZA
- Acronym
- SABR-MESCC
- Status last verified
- Sep 2024
- First submitted
- 6 Feb 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06613295
- Acronym / sponsor ID
- SABR-MESCC / CTO21003GZA
- Conditions
- Solid Tumor, Spinal Neoplasms, Spinal Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Cancer Research AntwerpUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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
- WHO performance status
- Acute and late toxicity assessment: as measured with CTCAE version 5.0
- Need for re-intervention, date and type of reintervention (surgery or radiotherapy), reason (wound infection, neurologic decline, loss of ability to walk or other)
- Pain response: VAS pain score
- 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:
- 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
- WHO performance status
- Concomitant medications and systemic anticancer therapies
- QoL according to the EORTC QLQ-C15 \& BM22 questionnaires
- Acute and late toxicity assessment: as measured with CTCAE version 5.0
- 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):
- 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
- Need for re-intervention, type of reintervention
- Survival data (survival status, date of death, primary cause of death)
- Local control (only if information is available in medical record as per standard of care)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Separation surgery followed by stereotactic ablative body radiotherapy | Active comparator | Radiation: SABR, Procedure: Separation surgerySurgery 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. |
| Stereotactic ablative body radiotherapy | Experimental | Radiation: SABRSABR 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SABRSABR | Radiation | Separation surgery followed by stereotactic ablative body radiotherapy, Stereotactic ablative body radiotherapy |
| Separation surgerySeparation surgery | Procedure or surgery | Separation surgery followed by stereotactic ablative body radiotherapy |
Primary outcome
Proportion of ambulant patients at 3 months
Time frame: 3 Months post treatment
The ambulatory status is scored binary (without or with aid vs not being able to walk)
8 secondary outcomes
Local recurrence rate
Time frame: Up to 24 months post treatment
Time to loss of ambulation
Time frame: Up to 24 months post treatment
Progression free survival (PFS)
Time frame: Up to 24 months post treatment
Overall survival
Time frame: Up to 24 months post treatment
Number of patients with re-intervention and time to re-intervention (surgery, RT, …)
Time frame: Up to 24 months post treatment
Acute and late toxicity
Time frame: Up to 6 months post treatment
Quality of life measurement by QLQ-BM22 and QLQ-C15-PAL questionnaires
Time frame: Up to 6 months post treatment
Pain response (VAS score)
Time frame: Up to 6 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Billiet, MD, PhD principal investigator
ZAS Augustinus
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SABR and Separation surgery in people with Solid Tumor and Spinal Neoplasms, run by Cancer Research Antwerp at 9 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Billiet, MD, PhD (03234433759, gza.cancertrials@zas.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ambulant patients at 3 months (time frame: 3 Months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.