Health TrialsbyHealthPanel

Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers

ConditionsBone MetastasesMetastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Histologically confirmed solid malignancy

Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)

Presence of up to five high-risk bone metastases

Disqualifiers

Prior radiotherapy to the index bone metastases preventing safe treatment planning

Symptomatic bone metastases requiring immediate palliative radiotherapy

Evidence of spinal cord compression

Bone metastases causing significant pain requiring opioid analgesics

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prophylactic External Beam Radiotherapy

    Radiation

    External beam radiotherapy delivered to up to five high-risk asymptomatic or minimally symptomatic bone metastases at a total dose of 25 Gy in 5 fractions.

  • Standard of Care

    Other intervention

    Systemic therapy or observation according to tumor type and clinical guidelines.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Prophylactic Radiotherapy + Standard of CareExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

1-year rate of skeletal-related events (SREs)

Number of participants experiencing at least one skeletal-related event (pathological fracture, spinal cord compression, need for radiation to bone, need for surgery to bone, or tumor-related hypercalcemia) within 12 months after randomization.

Time frame
From randomization to 12 months after randomization

Secondary outcomes

1

Incidence of adverse events

Adverse events assessed and graded according to CTCAE version 6.0

Time frame
Up to 12 months after randomization
2

EORTC QLQ-C30 global health status score

EORTC QLQ-C30 global health status score at each assessment time point (range: 0-100; higher scores indicate better quality of life).

Time frame
Baseline, 3 months, 6 months, and 12 months after randomization
3

EQ-5D-5L index score

EQ-5D-5L index score at each assessment time point (range typically from \<0 to 1; higher values indicate better health status).

Time frame
Baseline and follow-up visits up to 12 months after randomization
4

Brief Pain Inventory (BPI) pain intensity score

Pain intensity score measured using the Brief Pain Inventory (scale 0-10; higher scores indicate worse pain).

Time frame
Baseline and follow-up visits up to 12 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Oncology Ljubljana

Lead sponsor

Source ClinicalTrials.gov
Apply now