Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single

NCT04658537 | Active Not Recruiting DMC

• 1 other identifier: ASPIRE-single
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Radiotherapy; Radiotherapy, Intensity-Modulated

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (10)

• Treatment Wait Time

  1 week

• Radiation Department Time

  1 day

• Radiotherapy Treatment Time

  1 day

• Completion Rates of ePRO's in a Palliative Care Cohort

  2 years

• Comparing Patient and Carer Assessments

  2 years

Study Arms (2)

Standard Arm

ACTIVE COMPARATOR

8 Gy / 1 Fraction

Radiation: Radiation Therapy

Single Fraction Dose Escalation

EXPERIMENTAL

8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours

Single Fraction Dose Escalation; Standard Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic cancer
• Recommended for 8Gy/1# palliative radiation
• Patients with spinal cord compression are eligible for enrolment

You may not qualify if:

• Unwilling or unable to give informed consent
• Patients who are recommended multi fraction palliative radiation

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Related Publications (18)

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  PMID: 12573746 BACKGROUND

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  PMID: 21917431 BACKGROUND

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  PMID: 30555940 BACKGROUND

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  PMID: 30904024 BACKGROUND

• 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.

  PMID: 33851063 BACKGROUND

• 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.

  PMID: 31021390 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31505246 BACKGROUND

• 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.

  PMID: 15878101 BACKGROUND

• 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.

  PMID: 15738534 BACKGROUND

• 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.

  PMID: 19520448 BACKGROUND

• 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.

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  PMID: 23737690 BACKGROUND

• 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.

  BACKGROUND

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  PMID: 30102201 BACKGROUND

• 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.

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Related Links

• Varian. Varian Adaptive Therapy Ethos.

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Thomas Eade

  Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Treatment arm will be masked to investigators. Participants will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: Non Comparative Randomised Trial

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 8, 2020
• Study Start: June 29, 2021
• Primary Completion: October 4, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)