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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRoyal North Shore Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Metastatic cancer

Recommended for 5-10 fractions palliative radiation

Patients with spinal cord compression are eligible for enrolment

Disqualifiers

Unwilling or unable to give informed consent

Patients who are recommended for single fraction palliative radiation

Trial design

Design model

Parallel

Treatments tested in this trial

  • dose escalation

    Radiation

    single fraction dose escalation to the tumour

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: standardActive comparator 1 intervention
Group B: single fraction dose escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
9 months

Secondary outcomes

1

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

Time frame
2 years
2

Trial Safety

this will be determined by the radiation dose delivered to organs at risk and patient and carer reported toxicity from treatment

Time frame
2 years
3

Efficacy of treatment

Efficacy will be determined by reported treatment benefit, pain response, symptom control,re-treatment rates, overall survival and patient and carer regret

Time frame
2 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Royal North Shore HospitalRecruiting2065, Saint Leonards, New South WalesAustraliaAustralia

Sponsors and contacts

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Royal North Shore Hospital

Lead sponsor

Northern Sydney and Central Coast Area Health Service

Collaborator