Advanced Techniques For Single-fraction Palliative Radiot... | NCT04649125

Studies
Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation

NCT04649125

Sponsor

Royal North Shore Hospital

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Palliative Radiotherapy

Interventions

dose escalation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2021Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Nov 24, 2020

First Submission Date that Met QC Criteria

Nov 24, 2020

First Posted Date

Dec 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Name	Class
Northern Sydney and Central Coast Area Health Service	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to determine if single fraction dose escalated palliative radiotherapy results in a prolonged duration of benefit for patients otherwise suitable for Multifraction (5-10#) palliative radiation. The primary endpointis to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 12 months post treatment

Detailed Description

One third of patients treated in the radiation oncology department are treated with palliative intent. These patients are usually unwell due to their advanced disease and suffering from pain and other symptoms related to bony and soft tissue metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients. A meta-analysis of 29 randomised controlled trials (RCTs) estimated the overall response rate (ORR) following RT for bone metastases at approximately 60% with up to one quarter of patients experiencing a complete response (CR). However, palliative patients form a diverse group of patients and selecting the optimal number of palliative treatments which provides an enduring benefit while not being burdensome for the patient can be challenging. The ideal treatment is one that provides lasting symptom control and involves the least number of treatments. Up to one quarter of patients with advanced cancer who undergo palliative RT will die within 1 month of the treatment, while up to 50% of palliative patients will be alive at 12 months . In patients who receive a single fraction of 8Gy, up to 20% of these patients require retreatment to the same site, compared with 8% who receive multiple fraction treatment . One potential option to increase the duration of local control is with hypofractionated, dose escalated radiation.A phase II non-inferiority study investigated this hypothesis in non-spine bone metastases, comparing a single treatment of 12Gy to 30Gy in 10 fractions. The cohort reported a higher pain response in the single fraction dose escalated arm as early as 2 weeks post treatment (62 vs 32%), which was maintained at 9 months (77% vs 46% respectively).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard	Active Comparator	standard radiotherapy 5 fractions	Radiation: dose escalation
single fraction dose escalation	Experimental	8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume	Radiation: dose escalation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dose escalation	Radiation	single fraction dose escalation to the tumour	single fraction dose escalation standard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
benefit from palliative radiotherapy	to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment	9 months

Secondary Outcomes

Measure	Description	Time Frame
Feasibility of the trial	This will be assessed by the treatment wait time, the amount of time spent in the Radiation Department, the completion rates of electronic Patient Reported Outcome (ePRO)'s and comparing patient and carer assessments	2 years
Trial Safety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic cancer
Recommended for 5-10 fractions palliative radiation
Patients with spinal cord compression are eligible for enrolment

Exclusion Criteria:

Unwilling or unable to give informed consent
Patients who are recommended for single fraction palliative radiation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carol Kwong, RN	Contact	+61294631339	31339	carolyn.kwong@health.nsw.gov.au
Heidi Tsang, RN	Contact	+61294631340	31340	heidi.tsang@health.nsw.gov.au

Overall Officials

Name	Affiliation	Role
Thomas Eade	Northern Sydney Cancer Centre, Royal North Shore Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal North Shore Hospital	Recruiting	Saint Leonards	New South Wales	2065	Australia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The results of this trial will be published in a peer reviewed journal.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided