Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04658537




Registration number
NCT04658537
Ethics application status
Date submitted
24/11/2020
Date registered
8/12/2020
Date last updated
18/11/2023

Titles & IDs
Public title
Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single
Scientific title
Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
Secondary ID [1] 0 0
ASPIRE-single
Universal Trial Number (UTN)
Trial acronym
ASPIRE single
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Radiotherapy 0 0
Radiotherapy, Intensity-Modulated 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiation Therapy

Active Comparator: Standard Arm - 8 Gy / 1 Fraction

Experimental: Single Fraction Dose Escalation - 8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction


Treatment: Other: Radiation Therapy
Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substantial benefit from palliative radiotherapy
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Treatment Wait Time
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Radiation Department Time
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Radiotherapy Treatment Time
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
Completion Rates of ePRO's in a Palliative Care Cohort
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Comparing Patient and Carer Assessments
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Radiation Doses to Organs at Risk
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Patient Reported Outcomes
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Carer Reported Outcomes
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Efficacy of treatment
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Overall Survival
Timepoint [10] 0 0
2 years

Eligibility
Key inclusion criteria
- Metastatic cancer

- Recommended for 8Gy/1# palliative radiation

- Patients with spinal cord compression are eligible for enrolment
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unwilling or unable to give informed consent

- Patients who are recommended multi fraction palliative radiation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04658537
Trial related presentations / 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.
Rich 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. Erratum In: Radiother Oncol. 2019 Jun;135:201.
Caissie 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.
Sapienza 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.
Wu 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.
Schuler 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.
Nguyen 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. Erratum In: JAMA Oncol. 2021 Oct 1;7(10):1581.
Ryu 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.
Roos 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.
Maranzano 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.
Maranzano 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.
Lee 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.
Job 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.
Thavarajah 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.
Wong S, Roderick S, Atyeo JW, Grimberg K, Porter B, Booth J, et al. Improving the Palliative Patient Journey in Radiation Oncology. International Journal of Radiation Oncology • Biology • Physics. 2019;105(1):S49.
Sandler KA, Mitchell SA, Basch E, Raldow AC, Steinberg ML, Sharif J, Cook RR, Kupelian PA, McCloskey SA. Content Validity of Anatomic Site-Specific Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Sets for Assessment of Acute Symptomatic Toxicities in Radiation Oncology. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):44-52. doi: 10.1016/j.ijrobp.2018.04.048. Epub 2018 Jun 5.
Brunelli C, Zecca E, Martini C, Campa T, Fagnoni E, Bagnasco M, Lanata L, Caraceni A. Comparison of numerical and verbal rating scales to measure pain exacerbations in patients with chronic cancer pain. Health Qual Life Outcomes. 2010 Apr 22;8:42. doi: 10.1186/1477-7525-8-42.
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Eade
Address 0 0
Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dylan J Chin
Address 0 0
Country 0 0
Phone 0 0
+612 9463 1337
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04658537