Spinal Cord Compression Due to Metastasis to SpineRAMSES-01NCT04043156
RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
A study testing High-precision RT in people with Spinal Cord Compression Due to Metastasis to Spine, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
This clinical study aims to investigate whether high-precision radiotherapy, as supposed, leads to a better control of the irradiated spinal cord metastases when compared to conventional radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Compression Due to Metastasis to Spine
- What is being tested?
- High-precision RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 8 Aug 2019to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days
- Confirmation of diagnosis by MR-imaging (computed tomography [CT] allowed)
- Age 18 years or older
- Written informed consent
- Favorable survival prognosis (defined as 36-45 points on the survival score)
- Capacity of the patient to contract
Who cannot join
- Previous RT or surgery of the spinal areas affected by MSCC
- Symptomatic brain tumor or symptomatic brain metastases
- Metastases of the cervical spine only
- Other severe neurological disorders
- Pregnancy, Lactation
- Clear indication for spinal surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany
Lübeck, 23562
About this study
This clinical study aims to investigate whether high-precision radiotherapy, as supposed, leads to a better control of the irradiated spinal cord metastases when compared to conventional radiotherapy. This means that a progression or recurrence of motor deficits (weakness) of the legs following radiotherapy can be avoided more effectively. Furthermore, the high-precision radiotherapy will be compared to the conventional radiotherapy with respect to pain relief, motor function/ability to walk, quality of life, side effects and survival.
Read the detailed description
The aim of this single-arm study is to show that high-precision radiotherapy (RT) with 18x2.33 Gy in 3.5 weeks results in significantly better local progression free survival (LPFS) of metastatic spinal cord compression (MSCC) when compared to conventional RT with 10x3 Gy in 2 weeks. If such superiority could be shown, 18x2.33 Gy could be recommended, at least for those patients with favourable survival prognoses, since an in-field recurrence of MSCC in the irradiated part of the spine is generally very difficult to treat.
For this investigation the newly prospectively collected data will be compared with a historical cohort collected up to the time of data analysis.
The recruitment of all 65 patients (62 patients + 5% for potential drop-outs) is planned to be completed within 21 months. The follow-up period will be 12 months. This equals a total running time for the study of 33 months.
In accordance with a previous study assessing local control of MSCC, the following patient characteristics will be recorded to allow adequate comparison with the historical control group:
- Age
- Gender
- Type of primary tumor (breast cancer vs. prostate cancer vs. myeloma/ lymphoma vs. lung cancer vs. other tumors)
- Interval from tumor diagnosis to MSCC (≤15 months vs. >15 months)
- Number of involved vertebrae (1-2 vs. ≥3)
- Other bone metastases at the time of RT (no vs. yes)
- Visceral metastases at the time of RT (no vs. yes)
- Time developing motor deficits prior to RT (1-7 days vs. 8-14 days vs. >14 days)
- Ambulatory status prior to RT (no vs. yes)
- Eastern Cooperative Oncology Group (ECOG) performance score (0-2 vs- 3-4)
- Indication for decompressive surgery of affected spinal areas
The patients of this study who received high-precision RT with 18x2.33 Gy for MSCC will be compared to a historical control group of patients with a favorable survival prognosis who were treated with 10x3 Gy of conventional RT. The historical control group will include data from 235 patients qualifying for the comparison with the prospectively collected data.
Data for the historical control group will be collected from an already existing anonymized database with previous study data documented in the European Union.
To be eligible for control group, patients fulfilling the same inclusion criteria and exclusion criteria as defined in the prospective study are considered. Furthermore, to be consistent with efficacy analysis of the study, patients of the historical control group must have received at least 80% of the planned RT dose.
Propensity score techniques will be applied to reduce confounding due to differences between the historical control group and the prospective trial data.
- Being tested
- High-precision RT
- Keywords
- spinal cord compression, radiotherapy
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-precision RTRadiation
18 x 2.33 Gy of high-precision RT in 3.5 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-precision RT | Experimental | Study Arm: 18 x 2.33 Gy of high-precision RT in 3.5 weeks. Receives: Radiation: High-precision RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression-free survival at 12 months following RT.
LPFS time will be calculated from the last day of the RT. The evaluation will be performed in those patients, who are available for assessement of the Primary endpoint and have received at least 80% of the planned RT dose.
Measured: For each patient 12 months after the end of RT.
Secondary outcomes (8)
Change in motor function/ability to walk
Change in motor function is defined as improvement or deterioration by at least one point. 0=normal strength; 1=ambulatory without aid; 2 ambulatory with aid; 3=not ambulatory;4=complete paraplegia. Motor function will additionally be evaluated using additionally the American Spinal Injury Association (ASIA) classification resulting in total points of 0 to 14.
Measured: Assessment directly and at 1, 3, 6, 9 and 12 months after RT.
Change in quality of life
Quality of life (QoL) will be assessed using the distress thermometer. Patients can rate their impairment in QoL between 0 and 10 (no to maximum impairment). The data will be compared to the data documented prior to RT
Measured: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT
Change in vertebral pain
Vertebral pain will be evaluated with a numeric rating scale (self-assessment by patients ) from 0=no pain to 10=worst pain. Improvement by 2 points is rated partial response, 0 points complete response. The data will be compared to the data documented prior to RT. The intake of analgesics will be included.
Measured: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT
Overall survival
Will be calculated from the last day of RT up to 12 months following RT.
Measured: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT
Local progression-free survival
LPFS time will be calculated from the last day of the RT.
Measured: Additional evaluation directly and 1, 3, 6 and 9 months after RT
Occurence of toxicity
Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) 4.3. If radiation myelopathy is suspected, spinal Magnetic Resonance (MR)-Imaging will be performed. The data will be compared to the data documented prior to RT.
Measured: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT
Change in sensory function
Sensory function will be evaluated using the following scale, modified in accordance to the ASIA classification, 0=absent, 1=impaired, 2=normal, 9=cannot be assessed.
Measured: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT
Chance in sphincter dysfunction
Sphincter dysfunction will be evaluated as yes versus no.
Measured: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start8 Aug 2019
- Primary completion20 Dec 2022
- Study completion5 Jan 2023
Why it stopped: 52 of 65 planned patients were recruited. Since during the study, survival was worse than expected, a new survival score was developed, which was more precise than the tool used for the RAMSES-01 trial. As a consequence, the trial was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Compression Due to Metastasis to SpineStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study compared with a historical cohort.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dirk Rades, University Hopsital Schleswig Holstein Campus Lübeck
- Investigators
- Dirk Rades, Prof. Dr., Principal investigator, Dep. of Radiation Oncology, Univ. of Lübeck and Univ. Medical Center S-H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043156
- Sponsor's protocol ID
- RAMSES-01
- Acronym
- RAMSES-01
- Status last verified
- Jan 2023
- First submitted
- 30 Jul 2019
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rades D, Hansen O, Jensen LH, Dziggel L, Staackmann C, Doemer C, Cacicedo J, Conde-Moreno AJ, Segedin B, Ciervide-Jurio R, Rubio-Rodriguez C, Perez-Romasanta LA, Alvarez-Gracia A, Dennis K, Ferrer-Albiach C, Navarro-Martin A, Lopez-Campos F, Jankarashvili N, Janssen S, Olbrich D, Hollander NH. Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study. BMC Cancer. 2019 Nov 29;19(1):1163. doi: 10.1186/s12885-019-6390-x.
PubMed 31783816
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
- ClinicalTrials.gov ID
- NCT04043156
- Acronym / sponsor ID
- RAMSES-01 / RAMSES-01
- Keywords
- spinal cord compression, radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 52 of 65 planned patients were recruited. Since during the study, survival was worse than expected, a new survival score was developed, which was more precise than the tool used for the RAMSES-01 trial. As a consequence, the trial was terminated.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 2 Aug 2019 (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 clinical study aims to investigate whether high-precision radiotherapy, as supposed, leads to a better control of the irradiated spinal cord metastases when compared to conventional radiotherapy. This means that a progression or recurrence of motor deficits (weakness) of the legs following radiotherapy can be avoided more effectively. Furthermore, the high-precision radiotherapy will be compared to the conventional radiotherapy with respect to pain relief, motor function/ability to walk, quality of life, side effects and survival.
Detailed description
The aim of this single-arm study is to show that high-precision radiotherapy (RT) with 18x2.33 Gy in 3.5 weeks results in significantly better local progression free survival (LPFS) of metastatic spinal cord compression (MSCC) when compared to conventional RT with 10x3 Gy in 2 weeks. If such superiority could be shown, 18x2.33 Gy could be recommended, at least for those patients with favourable survival prognoses, since an in-field recurrence of MSCC in the irradiated part of the spine is generally very difficult to treat.
For this investigation the newly prospectively collected data will be compared with a historical cohort collected up to the time of data analysis.
The recruitment of all 65 patients (62 patients + 5% for potential drop-outs) is planned to be completed within 21 months. The follow-up period will be 12 months. This equals a total running time for the study of 33 months.
In accordance with a previous study assessing local control of MSCC, the following patient characteristics will be recorded to allow adequate comparison with the historical control group:
- Age
- Gender
- Type of primary tumor (breast cancer vs. prostate cancer vs. myeloma/ lymphoma vs. lung cancer vs. other tumors)
- Interval from tumor diagnosis to MSCC (≤15 months vs. >15 months)
- Number of involved vertebrae (1-2 vs. ≥3)
- Other bone metastases at the time of RT (no vs. yes)
- Visceral metastases at the time of RT (no vs. yes)
- Time developing motor deficits prior to RT (1-7 days vs. 8-14 days vs. >14 days)
- Ambulatory status prior to RT (no vs. yes)
- Eastern Cooperative Oncology Group (ECOG) performance score (0-2 vs- 3-4)
- Indication for decompressive surgery of affected spinal areas
The patients of this study who received high-precision RT with 18x2.33 Gy for MSCC will be compared to a historical control group of patients with a favorable survival prognosis who were treated with 10x3 Gy of conventional RT. The historical control group will include data from 235 patients qualifying for the comparison with the prospectively collected data.
Data for the historical control group will be collected from an already existing anonymized database with previous study data documented in the European Union.
To be eligible for control group, patients fulfilling the same inclusion criteria and exclusion criteria as defined in the prospective study are considered. Furthermore, to be consistent with efficacy analysis of the study, patients of the historical control group must have received at least 80% of the planned RT dose.
Propensity score techniques will be applied to reduce confounding due to differences between the historical control group and the prospective trial data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study compared with a historical cohort.
| Arm | Type | Receives |
|---|---|---|
| High-precision RT | Experimental | Radiation: High-precision RTStudy Arm: 18 x 2.33 Gy of high-precision RT in 3.5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days
- Confirmation of diagnosis by MR-imaging (computed tomography [CT] allowed)
- Age 18 years or older
- Written informed consent
- Favorable survival prognosis (defined as 36-45 points on the survival score)
Key exclusion criteria (6 listed)
- Previous RT or surgery of the spinal areas affected by MSCC
- Symptomatic brain tumor or symptomatic brain metastases
- Metastases of the cervical spine only
- Other severe neurological disorders
- Pregnancy, Lactation
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 |
|---|---|---|
| High-precision RT18 x 2.33 Gy of high-precision RT in 3.5 weeks | Radiation | High-precision RT |
Primary outcome
Local progression-free survival at 12 months following RT.
Time frame: For each patient 12 months after the end of RT.
LPFS time will be calculated from the last day of the RT. The evaluation will be performed in those patients, who are available for assessement of the Primary endpoint and have received at least 80% of the planned RT dose.
8 secondary outcomes
Change in motor function/ability to walk
Time frame: Assessment directly and at 1, 3, 6, 9 and 12 months after RT.
Change in quality of life
Time frame: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT
Change in vertebral pain
Time frame: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT
Overall survival
Time frame: Evaluation directly and at 1, 3, 6, 9 and 12 months after RT
Local progression-free survival
Time frame: Additional evaluation directly and 1, 3, 6 and 9 months after RT
Occurence of toxicity
Time frame: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT
Change in sensory function
Time frame: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT
Chance in sphincter dysfunction
Time frame: Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT
Results and safety
The study was stopped early (reason given: 52 of 65 planned patients were recruited. Since during the study, survival was worse than expected, a new survival score was developed, which was more precise than the tool used for the RAMSES-01 trial. As a consequence, the trial was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 31783816Rades D, Hansen O, Jensen LH, Dziggel L, Staackmann C, Doemer C, Cacicedo J, Conde-Moreno AJ, Segedin B, Ciervide-Jurio R, Rubio-Rodriguez C, Perez-Romasanta LA, Alvarez-Gracia A, Dennis K, Ferrer-Albiach C, Navarro-Martin A, Lopez-Campos F, Jankarashvili N, Janssen S, Olbrich D, Hollander NH. Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study. BMC Cancer. 2019 Nov 29;19(1):1163. doi: 10.1186/s12885-019-6390-x.
- 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. This study is not recruiting at the moment.
Dirk Rades, Prof. Dr. principal investigator
Dep. of Radiation Oncology, Univ. of Lübeck and Univ. Medical Center S-H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-precision RT in people with Spinal Cord Compression Due to Metastasis to Spine, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study was stopped early (reason given: 52 of 65 planned patients were recruited. Since during the study, survival was worse than expected, a new survival score was developed, which was more precise than the tool used for the RAMSES-01 trial. As a consequence, the trial was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression-free survival at 12 months following RT. (time frame: For each patient 12 months after the end of RT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043156, which also lists 1 linked publication.
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 15 Jan 2025.