Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000615482
Ethics application status
Approved
Date submitted
27/05/2025
Date registered
13/06/2025
Date last updated
29/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Feasibility and Safety of Conventional external beam radiation therapy (EBRT) and Integrated Stereotactic Gross Tumour Volume (GTV) Boost in Bone Metastases
Scientific title
The feasibility and safety of conventional EBRT and integrated stereotactic-lite GTV boost in bone metastases in participants with solid tumour
Secondary ID [1] 314541 0
None
Universal Trial Number (UTN)
Trial acronym
HYBRID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Metastases 337642 0
Condition category
Condition code
Cancer 333966 333966 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The HYBRID study is a prospective, multi-site clinical trial evaluating the feasibility and safety of combining conventional external beam radiation therapy (EBRT) with an integrated stereotactic LiTe (Low-intensity Targeted) Gross Tumour Volume (GTV) boost in patients with bone metastases from solid tumours. The intervention aims to enhance local control of metastatic lesions while maintaining acceptable toxicity profiles.

All participants will receive standard radiation treatment, which helps relieve pain and control the cancer.

In this study, the radiation schedule will be at the discretion of by the treating Doctor as to the best treatment for the individual patient. This schedule will be in one of 2 ways either:
once a day for 5 days over 1 week, or
once a day for 10 days over 2 weeks (Monday to Friday, with weekends off unless needed).
The treatment includes a standard radiation dose to the affected bone area, along with a more focused, higher-dose boost to the main tumour area using advanced imaging. advanced imaging technique. CT Scan (Computed Tomography) is used to support the planning and delivery of conventional external beam radiation therapy (EBRT) along with the higher-dose boost. This boost is designed to better target the cancer while protecting healthy tissue.

The Radiation treatment will be administered a radiation therapist. Depending on the schedule:
The 1-week option delivers 20 units of radiation (called Gray or Gy) to the broader area, with a focused boost of 25 Gy.
The 2-week option delivers 30 Gy to the broader area, with a focused boost of 36 Gy.
The goal is to see if this combined approach improves cancer control in the bones while keeping side effects low.

Adherence to the delivery of radiation treatment will be via data collected and reviewed with patient medical records.
Intervention code [1] 331167 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341624 0
Proportion of patients who initiate radiation therapy within 2 weeks (10 working days) of CT simulation, with a target rate of >80%.
Timepoint [1] 341624 0
This metric will be reported at the final analysis for all patients. Data collected from the first participant enrollment until 10 days post of last participant enrollment will enable the assessment of this timepoint. Number of patients who start treatment and number who underwent simulation will be collected via review of medical records.
Secondary outcome [1] 448114 0
Overall Survival (OS)
Timepoint [1] 448114 0
4 weeks, 3 months, and 6 months post-treatment.
Secondary outcome [2] 448474 0
To monitor the incidence of long-bone fractures at 3 and 6 months.
Timepoint [2] 448474 0
3 and 6 months post-radiation therapy.
Secondary outcome [3] 448111 0
To monitor the incidence of vertebral compression fractures (VCF) at 3 and 6 months.
Timepoint [3] 448111 0
3 and 6 months post-treatment.
Secondary outcome [4] 448112 0
To measure the need for reirradiation and salvage surgery at treated sites, evaluating the effectiveness of the initial treatment.
Timepoint [4] 448112 0
4 weeks, 3 months and 6 months post-treatment.
Secondary outcome [5] 448109 0
Proportion of patients achieving complete and partial pain response at 3 and 6 months, measured using the International Consensus on Palliative Radiotherapy Endpoints.
Timepoint [5] 448109 0
3 and 6 months post-radiation therapy.
Secondary outcome [6] 448110 0
Radiological Site-Specific Progression-Free Survival (RSS PFS) evaluated at 3 and 6 months, defined as no radiological evidence of local progression within the treated areas.
Timepoint [6] 448110 0
3 and 6 months post-treatment
Secondary outcome [7] 448113 0
To assess patient-reported outcomes (QOL) using EORTC QLQ-C30 and BM22 questionnaires at 4-weeks and 3- and 6-months
Timepoint [7] 448113 0
Baseline, 4 weeks, 3 months, and 6 months post-treatment.

Eligibility
Key inclusion criteria
1. Aged 18 years or older (21 years or older in Singapore).
2. Pathological diagnosis of a solid tumour (excluding germ cell tumours and small-cell cancers).
3. No planned change to pain medication on the first day of protocol radiotherapy.
4. Imaging-confirmed bone metastases on standard imaging (X-ray, WBBS, CT, MRI, or PET).
5. Pain score greater than or equal to 2 on the modified Brief Pain Inventory.
6. Estimated life expectancy greater than 3 months.
7. ECOG performance status of 0 to 2.
8. Ability to complete pain and quality of life assessments.
9. If treating the axial spine: at least 3 contiguous vertebral body segments involved.
10. Gross tumour volume (GTV) boost size must be greater than 1 cm.
11. A maximum of 3 GTV boost sites permitted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior radiotherapy or surgery to the intended treatment site.
2. Symptomatic spinal cord compression or cauda equina syndrome.
3. Spinal Instability Neoplastic Score (SINS) greater than 12.
4. Vertebral compression fracture with greater than 50% height loss or bony retropulsion (if spine is treated).
5. Mirels’ score greater than 9 for long bone metastases (if non-spinal bone is treated).
6. Systemic chemotherapy within 1 week before or after protocol radiotherapy.
7. Inability to provide informed consent.
8. Pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/06/2025
Actual
Date of last participant enrolment
Anticipated
13/06/2026
Actual
Date of last data collection
Anticipated
13/12/2026
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
Recruitment outside Australia
Country [1] 27106 0
Singapore
State/province [1] 27106 0

Funding & Sponsors
Funding source category [1] 319088 0
Commercial sector/Industry
Name [1] 319088 0
GenesisCare
Country [1] 319088 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
Country
Australia
Secondary sponsor category [1] 321550 0
None
Name [1] 321550 0
Address [1] 321550 0
Country [1] 321550 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317688 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 317688 0
Ethics committee country [1] 317688 0
Australia
Date submitted for ethics approval [1] 317688 0
17/03/2025
Approval date [1] 317688 0
21/05/2025
Ethics approval number [1] 317688 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141818 0
Prof Michael Chao
Address 141818 0
GenesisCare Ringwood Private Hospital 36 Mt Dandenong Rd Ringwood East VIC 3135
Country 141818 0
Australia
Phone 141818 0
+61 437 564 982
Fax 141818 0
Email 141818 0
[email protected]
Contact person for public queries
Name 141819 0
Kathryn Hogan
Address 141819 0
GenesisCare Building 7C &D, Level 1, the Mill, 41-43 Bourke Road Alexandria NSW 2015
Country 141819 0
Australia
Phone 141819 0
+61 456999676
Fax 141819 0
Email 141819 0
[email protected]
Contact person for scientific queries
Name 141820 0
Kathryn Hogan
Address 141820 0
GenesisCare Building 7C &D, Level 1, the Mill, 41-43 Bourke Road Alexandria NSW 2015
Country 141820 0
Australia
Phone 141820 0
+61 456999676
Fax 141820 0
Email 141820 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Patients are not providing consent to share Individual participant data



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.