Metastatic Epidural Spinal Cord CompressionSCORE-2NCT02189473
Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression
A study testing radiotherapy in people with Metastatic Epidural Spinal Cord Compression, run by Prof. Dirk Rades, MD at 15 sites in 6 countries.
Trial summary
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Metastatic Epidural Spinal Cord Compression
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Jul 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
- Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
- Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
- Written informed consent
Who cannot join
- Prior radiotherapy or surgery of the spinal areas affected by MESCC
- History of symptomatic brain tumor or symptomatic brain metastases
- Metastases of the cervical spine only
- Other severe neurological disorders
- Pregnancy, Lactation
- Indication for decompressive surgery + stabilization of the affected spinal areas
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Germany9 sites
Klinikum Bayreuth
Bayreuth, Bavaria, 95445
Charite Berlin
Berlin, 10117
Ruhr University
Bochum, North Rhine-Westphalia, 44801
Center of Radiotherapy and Radiation Oncology
Bremen, 28239
Radiotherapy Practice Dresden-Friedrichstadt
Dresden, Saxony, 01067
University of Lübeck
Lübeck, Schleswig-Holstein, 23538
Oberschwabenklinik Ravensburg
Ravensburg, Baden-Wutemberg, 88191
University of Regensburg
Regensburg, Bavaria, 93053
University of Würzburg
Würzburg, Bavaria, 97080
Spain2 sites
Cruces University Hospital
Barakaldo, Vizcaya (Basque Country), 48903
Consorcio Hospitalario Provencial de Castellon
Valencia, Castellon
About this study
Official title: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.
Read the detailed description
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression. The response rate (improvement in motor function or prevention of progression) will be assessed at one month following radiotherapy.
In addition, the following endpoints will be evaluated:
- Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy
- Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy
- Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy
- Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy
- Pain assessment directly and at 1, 3 and 6 months after radiotherapy
- Overall survival up to 6 months following radiotherapy
- Local Progression-free survival up to 6 months following radiotherapy
- Being tested
- radiotherapy
- Keywords
- metastatic epidural spinal cord compression, motor function, ambulatory status, pain, quality of life, overall survival, local control, toxicity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)
| Study group | Role | What they receive |
|---|---|---|
| 5 x 4 Gy in 1 week | Experimental | radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week) Receives: Radiation: radiotherapy |
| 10 x 3 Gy in 2 weeks | Active comparator | radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week) Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy
Overall response was defined as improvement or no further progression of motor deficits following radiotherapy.
Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength.
Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline. No further progression was defined as +/-1 point (i.e. +1 point, +/- 0 points or -1 point).
Measured: at 1 month following radiotherapy
Secondary outcomes (7)
Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy
Ambulatory status was assessed using the following scoring system:
0 = Normal strength
- = Ambulatory without aid
- = Ambulatory with aid
- = Not ambulatory
A patient with a score equal to or less than 2 is considered "able to walk". Both participants that could and could not walk prior to radiotherapy have been included in this assessment..
Measured: at 1 month following radiotherapy
Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy
Local Progression Free Survival (LPFS) was defined as freedom from progression of motor deficits during or one month following radiotherapy and freedom from in-field recurrence of metastatic spinal cord compression (MSCC) following radiotherapy.
An in-field recurrence was defined as a recurrence of MSCC associated with motor deficits in the region of the spinal cord that had been previously irradiated for MSCC.
In case of clinical suspicion of sich a recurrence, a spinal MRI was performed to confirm the diagnosis. Time to in-field recurrence was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month LPFS were estimated using the Kaplan-Meier method.
Measured: 6 months following radiotherapy
Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline
Distress (as an indicator of impairment of quality of life) was measured with the distress-thermometer. the patients rated their level of distress on a scale ranging from 0 (no distress) to 10 (extreme distress). Patients rated the distress they experienced during the last week and stated the reasons for distress from a list of items.
An improvement (lower score) by 2 points was considered a clinically relevant relief of distress. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible.
Measured: at 1 month following radiotherapy
Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline
Pain was measured with a numeric self-rating scale ranging from 0 (no pain) to 10 (worst pain).
Relief of pain was defined as improvement (=decrease of pain) by at least 2 points without increase of analgesics. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible.
Measured: at 1 month following radiotherapy
Number of Participants Who Were Alive at 6 Months Following Radiotherapy
Overall Survival (OS) was defined as freedom from death of any cause.
Time to death was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month OS were estimated using the Kaplan-Meier method.
Measured: 6 months following radiotherapy
Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy
Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength.
Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline.
Measured: at 1 month following radiotherapy
Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity
Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)
Measured: during radiotherapy and up to 6 months following radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Metastatic Epidural Spinal Cord CompressionStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dirk Rades, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein
- Investigators
- Dirk Rades, MD, Study chair, Department of Radiation Oncology, University of Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189473
- Sponsor's protocol ID
- ARO 200901
- Acronym
- SCORE-2
- Status last verified
- Feb 2020
- First submitted
- 7 Jul 2014
- Last updated
- 5 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Maranzano E, Latini P. Effectiveness of radiation therapy without surgery in metastatic spinal cord compression: final results from a prospective trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):959-67. doi: 10.1016/0360-3016(95)00572-g.
PubMed 7607970Sorensen S, Borgesen SE, Rohde K, Rasmusson B, Bach F, Boge-Rasmussen T, Stjernholm P, Larsen BH, Agerlin N, Gjerris F, et al. Metastatic epidural spinal cord compression. Results of treatment and survival. Cancer. 1990 Apr 1;65(7):1502-8. doi: 10.1002/1097-0142(19900401)65:73.0.co;2-d.
PubMed 2311062Helweg-Larsen S, Sorensen PS, Kreiner S. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables influencing survival and gait function in 153 patients. Int J Radiat Oncol Biol Phys. 2000 Mar 15;46(5):1163-9. doi: 10.1016/s0360-3016(99)00333-8.
PubMed 10725627Leviov M, Dale J, Stein M, Ben-Shahar M, Ben-Arush M, Milstein D, Goldsher D, Kuten A. The management of metastatic spinal cord compression: a radiotherapeutic success ceiling. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):231-4. doi: 10.1016/0360-3016(93)90232-k.
PubMed 8407396Rades D, Blach M, Bremer M, Wildfang I, Karstens JH, Heidenreich F. Prognostic significance of the time of developing motor deficits before radiation therapy in metastatic spinal cord compression: one-year results of a prospective trial. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1403-8. doi: 10.1016/s0360-3016(00)01408-5.
PubMed 11121640Rades D, Heidenreich F, Bremer M, Karstens JH. Time of developing motor deficits before radiotherapy as a new and relevant prognostic factor in metastatic spinal cord compression: final results of a retrospective analysis. Eur Neurol. 2001;45(4):266-9. doi: 10.1159/000052141.
PubMed 11385267Rades D, Heidenreich F, Karstens JH. Final results of a prospective study of the prognostic value of the time to develop motor deficits before irradiation in metastatic spinal cord compression. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):975-9. doi: 10.1016/s0360-3016(02)02819-5.
PubMed 12095565Arcangeli G, Giovinazzo G, Saracino B, D'Angelo L, Giannarelli D, Arcangeli G, Micheli A. Radiation therapy in the management of symptomatic bone metastases: the effect of total dose and histology on pain relief and response duration. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1119-26. doi: 10.1016/s0360-3016(98)00264-8.
PubMed 9869238Niewald M, Tkocz HJ, Abel U, Scheib T, Walter K, Nieder C, Schnabel K, Berberich W, Kubale R, Fuchs M. Rapid course radiation therapy vs. more standard treatment: a randomized trial for bone metastases. Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):1085-9. doi: 10.1016/s0360-3016(96)00388-4.
PubMed 89850308 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Bone Pain Trial Working Party. Radiother Oncol. 1999 Aug;52(2):111-21.
PubMed 10577696Steenland E, Leer JW, van Houwelingen H, Post WJ, van den Hout WB, Kievit J, de Haes H, Martijn H, Oei B, Vonk E, van der Steen-Banasik E, Wiggenraad RG, Hoogenhout J, Warlam-Rodenhuis C, van Tienhoven G, Wanders R, Pomp J, van Reijn M, van Mierlo I, Rutten E. The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study. Radiother Oncol. 1999 Aug;52(2):101-9. doi: 10.1016/s0167-8140(99)00110-3.
PubMed 10577695Rades D, Stalpers LJ, Veninga T, Schulte R, Hoskin PJ, Obralic N, Bajrovic A, Rudat V, Schwarz R, Hulshof MC, Poortmans P, Schild SE. Evaluation of five radiation schedules and prognostic factors for metastatic spinal cord compression. J Clin Oncol. 2005 May 20;23(15):3366-75. doi: 10.1200/JCO.2005.04.754.
PubMed 15908648Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22. doi: 10.1016/0360-3016(91)90171-y.
PubMed 2032882Barendsen GW. Dose fractionation, dose rate and iso-effect relationships for normal tissue responses. Int J Radiat Oncol Biol Phys. 1982 Nov;8(11):1981-97. doi: 10.1016/0360-3016(82)90459-x. No abstract available.
PubMed 6759484Koswig S, Budach V. [Remineralization and pain relief in bone metastases after after different radiotherapy fractions (10 times 3 Gy vs. 1 time 8 Gy). A prospective study]. Strahlenther Onkol. 1999 Oct;175(10):500-8. doi: 10.1007/s000660050061. German.
PubMed 10554645
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
- ClinicalTrials.gov ID
- NCT02189473
- Acronym / sponsor ID
- SCORE-2 / ARO 200901
- Keywords
- metastatic epidural spinal cord compression, motor function, ambulatory status, pain, quality of life, overall survival, local control, toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Prof. Dirk Rades, MDUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.
Detailed description
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression. The response rate (improvement in motor function or prevention of progression) will be assessed at one month following radiotherapy.
In addition, the following endpoints will be evaluated:
- Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy
- Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy
- Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy
- Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy
- Pain assessment directly and at 1, 3 and 6 months after radiotherapy
- Overall survival up to 6 months following radiotherapy
- Local Progression-free survival up to 6 months following radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 x 4 Gy in 1 week | Experimental | Radiation: radiotherapyradiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week) |
| 10 x 3 Gy in 2 weeks | Active comparator | Radiation: radiotherapyradiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
- Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
- Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
- Written informed consent
Key exclusion criteria (6 listed)
- Prior radiotherapy or surgery of the spinal areas affected by MESCC
- History of 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 |
|---|---|---|
| radiotherapyexternal beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy) | Radiation | 10 x 3 Gy in 2 weeks, 5 x 4 Gy in 1 week |
Primary outcome
Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy
Time frame: at 1 month following radiotherapy
Overall response was defined as improvement or no further progression of motor deficits following radiotherapy. Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength. Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline. No further progression was defined as +/-1 point (i.e. +1 point, +/- 0 points or -1 point).
7 secondary outcomes
Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy
Time frame: at 1 month following radiotherapy
Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy
Time frame: 6 months following radiotherapy
Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline
Time frame: at 1 month following radiotherapy
Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline
Time frame: at 1 month following radiotherapy
Number of Participants Who Were Alive at 6 Months Following Radiotherapy
Time frame: 6 months following radiotherapy
Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy
Time frame: at 1 month following radiotherapy
Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity
Time frame: during radiotherapy and up to 6 months following radiotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7607970Maranzano E, Latini P. Effectiveness of radiation therapy without surgery in metastatic spinal cord compression: final results from a prospective trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):959-67. doi: 10.1016/0360-3016(95)00572-g.
- Background: PubMed 2311062Sorensen S, Borgesen SE, Rohde K, Rasmusson B, Bach F, Boge-Rasmussen T, Stjernholm P, Larsen BH, Agerlin N, Gjerris F, et al. Metastatic epidural spinal cord compression. Results of treatment and survival. Cancer. 1990 Apr 1;65(7):1502-8. doi: 10.1002/1097-0142(19900401)65:73.0.co;2-d.
- Background: PubMed 10725627Helweg-Larsen S, Sorensen PS, Kreiner S. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables influencing survival and gait function in 153 patients. Int J Radiat Oncol Biol Phys. 2000 Mar 15;46(5):1163-9. doi: 10.1016/s0360-3016(99)00333-8.
- Background: PubMed 8407396Leviov M, Dale J, Stein M, Ben-Shahar M, Ben-Arush M, Milstein D, Goldsher D, Kuten A. The management of metastatic spinal cord compression: a radiotherapeutic success ceiling. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):231-4. doi: 10.1016/0360-3016(93)90232-k.
- Background: PubMed 11121640Rades D, Blach M, Bremer M, Wildfang I, Karstens JH, Heidenreich F. Prognostic significance of the time of developing motor deficits before radiation therapy in metastatic spinal cord compression: one-year results of a prospective trial. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1403-8. doi: 10.1016/s0360-3016(00)01408-5.
- Background: PubMed 11385267Rades D, Heidenreich F, Bremer M, Karstens JH. Time of developing motor deficits before radiotherapy as a new and relevant prognostic factor in metastatic spinal cord compression: final results of a retrospective analysis. Eur Neurol. 2001;45(4):266-9. doi: 10.1159/000052141.
- Background: PubMed 12095565Rades D, Heidenreich F, Karstens JH. Final results of a prospective study of the prognostic value of the time to develop motor deficits before irradiation in metastatic spinal cord compression. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):975-9. doi: 10.1016/s0360-3016(02)02819-5.
- Background: PubMed 9869238Arcangeli G, Giovinazzo G, Saracino B, D'Angelo L, Giannarelli D, Arcangeli G, Micheli A. Radiation therapy in the management of symptomatic bone metastases: the effect of total dose and histology on pain relief and response duration. Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1119-26. doi: 10.1016/s0360-3016(98)00264-8.
- Background: PubMed 8985030Niewald M, Tkocz HJ, Abel U, Scheib T, Walter K, Nieder C, Schnabel K, Berberich W, Kubale R, Fuchs M. Rapid course radiation therapy vs. more standard treatment: a randomized trial for bone metastases. Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):1085-9. doi: 10.1016/s0360-3016(96)00388-4.
- Background: PubMed 105776968 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Bone Pain Trial Working Party. Radiother Oncol. 1999 Aug;52(2):111-21.
- Background: PubMed 10577695Steenland E, Leer JW, van Houwelingen H, Post WJ, van den Hout WB, Kievit J, de Haes H, Martijn H, Oei B, Vonk E, van der Steen-Banasik E, Wiggenraad RG, Hoogenhout J, Warlam-Rodenhuis C, van Tienhoven G, Wanders R, Pomp J, van Reijn M, van Mierlo I, Rutten E. The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study. Radiother Oncol. 1999 Aug;52(2):101-9. doi: 10.1016/s0167-8140(99)00110-3.
- Background: PubMed 15908648Rades D, Stalpers LJ, Veninga T, Schulte R, Hoskin PJ, Obralic N, Bajrovic A, Rudat V, Schwarz R, Hulshof MC, Poortmans P, Schild SE. Evaluation of five radiation schedules and prognostic factors for metastatic spinal cord compression. J Clin Oncol. 2005 May 20;23(15):3366-75. doi: 10.1200/JCO.2005.04.754.
- 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, MD study chair
Department of Radiation Oncology, University of Lübeck, Germany
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy in people with Metastatic Epidural Spinal Cord Compression, run by Prof. Dirk Rades, MD at 15 sites in 6 countries.
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 4 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: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Spain, United States, Lithuania, Saudi Arabia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy (time frame: at 1 month following radiotherapy). 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 NCT02189473, which also lists 20 linked publications.
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 5 Mar 2020.