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

NCT ID: NCT04649125

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2026-06-30

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).

Conditions

Palliative Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard

standard radiotherapy 5 fractions

Group Type: ACTIVE_COMPARATOR

dose escalation

Intervention Type: RADIATION

single fraction dose escalation to the tumour

single fraction dose escalation

8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume

Group Type: EXPERIMENTAL

dose escalation

Intervention Type: RADIATION

single fraction dose escalation to the tumour

Interventions

dose escalation

single fraction dose escalation to the tumour

Intervention Type: RADIATION

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal North Shore Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Thomas Eade

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Eade

Role: PRINCIPAL_INVESTIGATOR

Northern Sydney Cancer Centre, Royal North Shore Hospital

Locations

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Carol Kwong, RN

Role: CONTACT

carolyn.kwong@health.nsw.gov.au

+61294631339 ext. 31339

Heidi Tsang, RN

Role: CONTACT

heidi.tsang@health.nsw.gov.au

+61294631340 ext. 31340

Facility Contacts

Carol Kwong, RN

Role: primary

carolyn.kwong@health.nsw.gov.au

+61294631339 ext. 31339

Heidi Tsang, RN

Role: backup

heidi.tsang@health.nsw.gov.au

+61294631340 ext. 31340

Other Identifiers

ASPIRE Multi

Identifier Type: -

Identifier Source: org_study_id