Palliative RadiotherapyASPIRE singleNCT04658537
Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single
A study testing Radiation Therapy in people with Palliative Radiotherapy and Radiotherapy, Intensity-Modulated, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
One third of patients treated in the radiation oncology departments are treated with palliative intent. These patients can be unwell due to their advanced disease and suffering from pain and other symptoms related to metastases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Radiotherapy, Radiotherapy, Intensity-Modulated
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Jun 2021to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Metastatic cancer
- Recommended for 8Gy/1# palliative radiation
- Patients with spinal cord compression are eligible for enrolment
Who cannot join
- Unwilling or unable to give informed consent
- Patients who are recommended multi fraction palliative radiation
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
About this study
Official title: Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
One third of patients treated in the radiation oncology departments are treated with palliative intent. These patients can be unwell due to their advanced disease and suffering from pain and other symptoms related to metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients.The aim of the study is to determine if escalated single fraction palliative radiotherapy using intensity-modulated techniques results in a prolonged duration of benefit for patients otherwise suitable for standard single fraction radiotherapy.
Read the detailed description
Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for palliative patients who can be unwell due to their advanced disease and who suffer from pain and other symptoms related to metastases.
A single fraction of 8Gy is considered a standard treatment. In an assessment of health related quality of life (HRQoL) after palliative RT for painful bone metastases, the overall radiotherapy response at 1 week was 45% and by week 2 was 62%. Patients had a significant decrease in pain, insomnia and constipation by 1 month post treatment and an improvement in emotional functioning. When RT is used to control a bleeding tumour, up to 90% of patients will experience haemostasis.
There is however concern that 8 Gy in 1 fraction will not provide a durable response, with up to 20% of patients requiring retreatment to the same site, compared with 8% who receive multiple fraction treatment. Single fraction palliative radiation therapy (SFRT) is therefore an under utilised treatment regimen.
To implement the higher doses with a single fraction, more advanced radiation techniques are required, and there is still equipoise regarding the benefits. With advances in linear accelerator design and software, it is now possible to treat patients with advanced radiation techniques and low resources. Standard clinical pathways including computer optimised planning, remote (virtual) QA of plan delivery and the use of diagnostic imaging for planning are all feasible (under currently in clinical use at Northern Sydney Cancer Centre).
The results from this study will be used to design / proceed to a Randomised Phase III study, if appropriate.
- Being tested
- Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Active comparator | 8 Gy / 1 Fraction Receives: Radiation: Radiation Therapy |
| Single Fraction Dose Escalation | Experimental | 8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substantial benefit from palliative radiotherapy
to determine the percentage of patients who achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment.
Measured: 9 months
Secondary outcomes (10)
Treatment Wait Time
The time from the date of the initial consultation and radiation therapy consent to the start date of radiation therapy
Measured: 1 week
Radiation Department Time
The time in the radiation oncology department for radiation therapy, from arrival time in the department until the patient is ready for collection at the end of treatment
Measured: 1 day
Radiotherapy Treatment Time
The time that the patient is in the Radiation therapy treatment room, from time of entry to time of exit
Measured: 1 day
Completion Rates of ePRO's in a Palliative Care Cohort
The rate at which baseline and post treatment questionnaires are completed by both patients and primary carers
Measured: 2 years
Comparing Patient and Carer Assessments
Comparing the answers given by patients and carers to determine whether carers can accurately answer on behalf of patients
Measured: 2 years
Radiation Doses to Organs at Risk
The radiation doses delivered to the surrounding organs at risk will be reviewed during and after treatment completion to ensure that they meet predefined OAR constraints Patient and carer reported toxicity from treatment
Measured: 2 years
Patient Reported Outcomes
Electronic questionnaires delivered to the patient pre-treatment and post treatment at 1, 3, 6, 9, 12, 18, and 24 months. Scores will be calculated in accordance with established scoring methods
Measured: 24 months
Carer Reported Outcomes
Electronic questionnaires delivered to the patient's primary carer pre-treatment and post treatment at 1, 3, 6, 9, 12, 18, and 24 months. Scores will be calculated in accordance with established scoring methods
Measured: 24 months
Efficacy of treatment
this will be determined by re-treatment rates of irradiated sites, symptom control and recurrence
Measured: 2 years
Overall Survival
This will be defined as the time to death measured from the day of randomisation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start29 Jun 2021
- Primary completion4 Oct 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Palliative RadiotherapyStudies 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
- Model description
- Non Comparative Randomised Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Thomas Eade, Royal North Shore Hospital
- Investigators
- Thomas Eade, Principal investigator, Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658537
- Sponsor's protocol ID
- ASPIRE-single
- Acronym
- ASPIRE single
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2020
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this trial will be published in a peer reviewed journal. Target journals for publication of this trial include, International Journal of Radiation Oncology Biology Physics
Publications
Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
PubMed 12573746Rich SE, Chow R, Raman S, Liang Zeng K, Lutz S, Lam H, Silva MF, Chow E. Update of the systematic review of palliative radiation therapy fractionation for bone metastases. Radiother Oncol. 2018 Mar;126(3):547-557. doi: 10.1016/j.radonc.2018.01.003. Epub 2018 Feb 1.
PubMed 29397209Caissie A, Zeng L, Nguyen J, Zhang L, Jon F, Dennis K, Holden L, Culleton S, Koo K, Tsao M, Barnes E, Danjoux C, Sahgal A, Simmons C, Chow E. Assessment of health-related quality of life with the European Organization for Research and Treatment of Cancer QLQ-C15-PAL after palliative radiotherapy of bone metastases. Clin Oncol (R Coll Radiol). 2012 Mar;24(2):125-33. doi: 10.1016/j.clon.2011.08.008. Epub 2011 Sep 13.
PubMed 21917431Sapienza LG, Ning MS, Jhingran A, Lin LL, Leao CR, da Silva BB, Pellizzon ACA, Gomes MJL, Baiocchi G. Short-course palliative radiation therapy leads to excellent bleeding control: A single centre retrospective study. Clin Transl Radiat Oncol. 2018 Nov 22;14:40-46. doi: 10.1016/j.ctro.2018.11.007. eCollection 2019 Jan.
PubMed 30555940Wu SY, Singer L, Boreta L, Garcia MA, Fogh SE, Braunstein SE. Palliative radiotherapy near the end of life. BMC Palliat Care. 2019 Mar 23;18(1):29. doi: 10.1186/s12904-019-0415-8.
PubMed 30904024Schuler T, Back M, Hruby G, Carroll S, Jayamanne D, Kneebone A, Stevens M, Lamoury G, Morgia M, Wong S, Grimberg K, Roderick S, Booth J, Eade T. Introducing Computed Tomography Simulation-Free and Electronic Patient-Reported Outcomes-Monitored Palliative Radiation Therapy into Routine Care: Clinical Outcomes and Implementation Experience. Adv Radiat Oncol. 2020 Dec 3;6(2):100632. doi: 10.1016/j.adro.2020.100632. eCollection 2021 Mar-Apr.
PubMed 33851063Nguyen QN, Chun SG, Chow E, Komaki R, Liao Z, Zacharia R, Szeto BK, Welsh JW, Hahn SM, Fuller CD, Moon BS, Bird JE, Satcher R, Lin PP, Jeter M, O'Reilly MS, Lewis VO. Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial. JAMA Oncol. 2019 Jun 1;5(6):872-878. doi: 10.1001/jamaoncol.2019.0192.
PubMed 31021390Ryu S, Deshmukh S, Timmerman RD, Movsas B, Gerszten PC, Yin FF, et al. Radiosurgery Compared To External Beam Radiotherapy for Localized Spine Metastasis: Phase III Results of NRG Oncology/RTOG 0631. International Journal of Radiation Oncology • Biology • Physics. 2019;105(1):S2-S3.
Ong WL, Foroudi F, Milne RL, Millar JL. Variation in the Use of Single- Versus Multifraction Palliative Radiation Therapy for Bone Metastases in Australia. Int J Radiat Oncol Biol Phys. 2020 Jan 1;106(1):61-66. doi: 10.1016/j.ijrobp.2019.08.061. Epub 2019 Sep 7.
PubMed 31505246Roos DE, Turner SL, O'Brien PC, Smith JG, Spry NA, Burmeister BH, Hoskin PJ, Ball DL; Trans-Tasman Radiation Oncology Group, TROG 96.05. Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05). Radiother Oncol. 2005 Apr;75(1):54-63. doi: 10.1016/j.radonc.2004.09.017. Epub 2004 Oct 28.
PubMed 15878101Maranzano E, Bellavita R, Rossi R, De Angelis V, Frattegiani A, Bagnoli R, Mignogna M, Beneventi S, Lupattelli M, Ponticelli P, Biti GP, Latini P. Short-course versus split-course radiotherapy in metastatic spinal cord compression: results of a phase III, randomized, multicenter trial. J Clin Oncol. 2005 May 20;23(15):3358-65. doi: 10.1200/JCO.2005.08.193. Epub 2005 Feb 28.
PubMed 15738534Maranzano E, Trippa F, Casale M, Costantini S, Lupattelli M, Bellavita R, Marafioti L, Pergolizzi S, Santacaterina A, Mignogna M, Silvano G, Fusco V. 8Gy single-dose radiotherapy is effective in metastatic spinal cord compression: results of a phase III randomized multicentre Italian trial. Radiother Oncol. 2009 Nov;93(2):174-9. doi: 10.1016/j.radonc.2009.05.012. Epub 2009 Jun 10.
PubMed 19520448Lee KA, Dunne M, Small C, Kelly PJ, McArdle O, O'Sullivan J, Hacking D, Pomeroy M, Armstrong J, Moriarty M, Clayton-Lea A, Parker I, Collins CD, Thirion P. (ICORG 05-03): prospective randomized non-inferiority phase III trial comparing two radiation schedules in malignant spinal cord compression (not proceeding with surgical decompression); the quality of life analysis. Acta Oncol. 2018 Jul;57(7):965-972. doi: 10.1080/0284186X.2018.1433320. Epub 2018 Feb 8.
PubMed 29419331Job M, Holt T, Bernard A. Reducing radiotherapy waiting times for palliative patients: The role of the Advanced Practice Radiation Therapist. J Med Radiat Sci. 2017 Dec;64(4):274-280. doi: 10.1002/jmrs.243. Epub 2017 Aug 29.
PubMed 28851033Thavarajah N, Wong K, Zhang L, Bedard G, Wong E, Tsao M, Danjoux C, Barnes E, Sahgal A, Dennis K, Holden L, Lauzon N, Chow E. Continued success in providing timely palliative radiation therapy at the Rapid Response Radiotherapy Program: a review of 2008-2012. Curr Oncol. 2013 Jun;20(3):e206-11. doi: 10.3747/co.20.1342.
PubMed 23737690
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
- ClinicalTrials.gov ID
- NCT04658537
- Acronym / sponsor ID
- ASPIRE single / ASPIRE-single
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2020 (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.
One third of patients treated in the radiation oncology departments are treated with palliative intent. These patients can be unwell due to their advanced disease and suffering from pain and other symptoms related to metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients.The aim of the study is to determine if escalated single fraction palliative radiotherapy using intensity-modulated techniques results in a prolonged duration of benefit for patients otherwise suitable for standard single fraction radiotherapy.
Detailed description
Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for palliative patients who can be unwell due to their advanced disease and who suffer from pain and other symptoms related to metastases.
A single fraction of 8Gy is considered a standard treatment. In an assessment of health related quality of life (HRQoL) after palliative RT for painful bone metastases, the overall radiotherapy response at 1 week was 45% and by week 2 was 62%. Patients had a significant decrease in pain, insomnia and constipation by 1 month post treatment and an improvement in emotional functioning. When RT is used to control a bleeding tumour, up to 90% of patients will experience haemostasis.
There is however concern that 8 Gy in 1 fraction will not provide a durable response, with up to 20% of patients requiring retreatment to the same site, compared with 8% who receive multiple fraction treatment. Single fraction palliative radiation therapy (SFRT) is therefore an under utilised treatment regimen.
To implement the higher doses with a single fraction, more advanced radiation techniques are required, and there is still equipoise regarding the benefits. With advances in linear accelerator design and software, it is now possible to treat patients with advanced radiation techniques and low resources. Standard clinical pathways including computer optimised planning, remote (virtual) QA of plan delivery and the use of diagnostic imaging for planning are all feasible (under currently in clinical use at Northern Sydney Cancer Centre).
The results from this study will be used to design / proceed to a Randomised Phase III study, if appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Non Comparative Randomised Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Active comparator | Radiation: Radiation Therapy8 Gy / 1 Fraction |
| Single Fraction Dose Escalation | Experimental | Radiation: Radiation Therapy8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Metastatic cancer
- Recommended for 8Gy/1# palliative radiation
- Patients with spinal cord compression are eligible for enrolment
Key exclusion criteria (2 listed)
- Unwilling or unable to give informed consent
- Patients who are recommended multi fraction palliative radiation
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 |
|---|---|---|
| Radiation TherapyCancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours | Radiation | Single Fraction Dose Escalation, Standard Arm |
Primary outcome
Substantial benefit from palliative radiotherapy
Time frame: 9 months
to determine the percentage of patients who achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment.
10 secondary outcomes
Treatment Wait Time
Time frame: 1 week
Radiation Department Time
Time frame: 1 day
Radiotherapy Treatment Time
Time frame: 1 day
Completion Rates of ePRO's in a Palliative Care Cohort
Time frame: 2 years
Comparing Patient and Carer Assessments
Time frame: 2 years
Radiation Doses to Organs at Risk
Time frame: 2 years
Patient Reported Outcomes
Time frame: 24 months
Carer Reported Outcomes
Time frame: 24 months
Efficacy of treatment
Time frame: 2 years
Overall Survival
Time frame: 2 years
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 5 Feb 2026.
- Background: PubMed 12573746Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
- Background: PubMed 29397209Rich SE, Chow R, Raman S, Liang Zeng K, Lutz S, Lam H, Silva MF, Chow E. Update of the systematic review of palliative radiation therapy fractionation for bone metastases. Radiother Oncol. 2018 Mar;126(3):547-557. doi: 10.1016/j.radonc.2018.01.003. Epub 2018 Feb 1.
- Background: PubMed 21917431Caissie A, Zeng L, Nguyen J, Zhang L, Jon F, Dennis K, Holden L, Culleton S, Koo K, Tsao M, Barnes E, Danjoux C, Sahgal A, Simmons C, Chow E. Assessment of health-related quality of life with the European Organization for Research and Treatment of Cancer QLQ-C15-PAL after palliative radiotherapy of bone metastases. Clin Oncol (R Coll Radiol). 2012 Mar;24(2):125-33. doi: 10.1016/j.clon.2011.08.008. Epub 2011 Sep 13.
- Background: PubMed 30555940Sapienza LG, Ning MS, Jhingran A, Lin LL, Leao CR, da Silva BB, Pellizzon ACA, Gomes MJL, Baiocchi G. Short-course palliative radiation therapy leads to excellent bleeding control: A single centre retrospective study. Clin Transl Radiat Oncol. 2018 Nov 22;14:40-46. doi: 10.1016/j.ctro.2018.11.007. eCollection 2019 Jan.
- Background: PubMed 30904024Wu SY, Singer L, Boreta L, Garcia MA, Fogh SE, Braunstein SE. Palliative radiotherapy near the end of life. BMC Palliat Care. 2019 Mar 23;18(1):29. doi: 10.1186/s12904-019-0415-8.
- Background: PubMed 33851063Schuler T, Back M, Hruby G, Carroll S, Jayamanne D, Kneebone A, Stevens M, Lamoury G, Morgia M, Wong S, Grimberg K, Roderick S, Booth J, Eade T. Introducing Computed Tomography Simulation-Free and Electronic Patient-Reported Outcomes-Monitored Palliative Radiation Therapy into Routine Care: Clinical Outcomes and Implementation Experience. Adv Radiat Oncol. 2020 Dec 3;6(2):100632. doi: 10.1016/j.adro.2020.100632. eCollection 2021 Mar-Apr.
- Background: PubMed 31021390Nguyen QN, Chun SG, Chow E, Komaki R, Liao Z, Zacharia R, Szeto BK, Welsh JW, Hahn SM, Fuller CD, Moon BS, Bird JE, Satcher R, Lin PP, Jeter M, O'Reilly MS, Lewis VO. Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial. JAMA Oncol. 2019 Jun 1;5(6):872-878. doi: 10.1001/jamaoncol.2019.0192.
- BackgroundRyu S, Deshmukh S, Timmerman RD, Movsas B, Gerszten PC, Yin FF, et al. Radiosurgery Compared To External Beam Radiotherapy for Localized Spine Metastasis: Phase III Results of NRG Oncology/RTOG 0631. International Journal of Radiation Oncology • Biology • Physics. 2019;105(1):S2-S3.
- Background: PubMed 31505246Ong WL, Foroudi F, Milne RL, Millar JL. Variation in the Use of Single- Versus Multifraction Palliative Radiation Therapy for Bone Metastases in Australia. Int J Radiat Oncol Biol Phys. 2020 Jan 1;106(1):61-66. doi: 10.1016/j.ijrobp.2019.08.061. Epub 2019 Sep 7.
- Background: PubMed 15878101Roos DE, Turner SL, O'Brien PC, Smith JG, Spry NA, Burmeister BH, Hoskin PJ, Ball DL; Trans-Tasman Radiation Oncology Group, TROG 96.05. Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05). Radiother Oncol. 2005 Apr;75(1):54-63. doi: 10.1016/j.radonc.2004.09.017. Epub 2004 Oct 28.
- Background: PubMed 15738534Maranzano E, Bellavita R, Rossi R, De Angelis V, Frattegiani A, Bagnoli R, Mignogna M, Beneventi S, Lupattelli M, Ponticelli P, Biti GP, Latini P. Short-course versus split-course radiotherapy in metastatic spinal cord compression: results of a phase III, randomized, multicenter trial. J Clin Oncol. 2005 May 20;23(15):3358-65. doi: 10.1200/JCO.2005.08.193. Epub 2005 Feb 28.
- Background: PubMed 19520448Maranzano E, Trippa F, Casale M, Costantini S, Lupattelli M, Bellavita R, Marafioti L, Pergolizzi S, Santacaterina A, Mignogna M, Silvano G, Fusco V. 8Gy single-dose radiotherapy is effective in metastatic spinal cord compression: results of a phase III randomized multicentre Italian trial. Radiother Oncol. 2009 Nov;93(2):174-9. doi: 10.1016/j.radonc.2009.05.012. Epub 2009 Jun 10.
- Varian. Varian Adaptive Therapy Ethos.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The results of this trial will be published in a peer reviewed journal. Target journals for publication of this trial include, International Journal of Radiation Oncology Biology Physics
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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.
Thomas Eade principal investigator
Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Palliative Radiotherapy and Radiotherapy, Intensity-Modulated, run by Royal North Shore Hospital at 1 site in Australia.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. 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 Australia. 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?
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?
Substantial benefit from palliative radiotherapy (time frame: 9 months). 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 NCT04658537, which also lists 18 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 Feb 2026.