Comparing two radiation therapies for treating bone metastases in cancer patients

A Randomised, Prospective, Monoinstitutional Study of Ablative Radiosurgery vs Stereotactic Radiotherapy in 5 Fractions, With Simultaneous Integrated Boost, for the Treatment of Bone Lesions in Oligometastatic Disease

This study is testing two different types of radiation therapy for cancer patients with bone metastases to see which one works better in treating their condition.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 307 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Milan, MI)
• Trial ID: NCT05679427 on ClinicalTrials.gov

What this trial studies

This study compares two radiation therapy approaches for patients with oligometastatic bone lesions: ablative radiosurgery delivering up to 24 Gy and stereotactic radiotherapy with simultaneous integrated boost (SIB) delivering up to 50 Gy. Patients will be randomly assigned to one of the two treatment groups after meeting specific inclusion criteria. The study aims to evaluate the effectiveness of these treatments in managing bone metastases with a radical intent. An interim analysis will be conducted after 12 months to assess major endpoints.

Who should consider this trial

Good fit: Ideal candidates include patients with oligometastatic disease who have 1 to 5 metastases and a performance status of ECOG ≤2.

Not a fit: Patients with serious medical comorbidities or those with disease sites not eligible for stereotactic radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more effective treatment options for patients with oligometastatic bone lesions, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promising results with similar radiation therapy approaches, indicating potential for success in this study.

Eligibility criteria

Inclusion Criteria:

* Performance status ECOG ≤2
* Life expectancy \> 6 months according to Mizumoto criteria\*
* Oligometastatic disease (Total number of metastases from 1 to 5: both synchronous and metachronous with maximum involvement of three organs in total - lymph nodes, bones, lungs, liver, adrenal gland, brain- with known histology
* At least one bone metastasis treatable with SABR or SRS
* Each secondary localization (synchronous, metachronous or oligoprogressive) must be treated with radical intent.
* Patients may have received other anticancer treatments (surgery for initial site of disease or other metastases, chemotherapy, radiotherapy for other metastatic sites)

Exclusion Criteria:

* Sites of disease not eligible for stereotactic radiotherapy
* Serious medical comorbidities that preclude RT
* Overlap with a previously treated volume of radiotherapy
* Dimension greater than 5 cm for extra-cranial lesions.
* Size greater than 3 cm for brain lesions
* More than 1 brain metastases
* Clinical or radiological evidence of spinal cord compression or epidural tumor within 2mm of the spinal cord
* Radiological evidence of vertebral body fracture or involvement of more than 40% of the vertebral body
* Radiological evidence of cortical involvement in long bones
* Pregnant or breastfeeding women

Where this trial is running

Milan, MI

• San Raffaele Scientific Institute — Milan, MI, Italy (RECRUITING)

Study contacts

• Principal investigator: Nadia G Di Muzio, Prof — IRCCS San Raffaele, Milan
• Study coordinator: Nadia G Di Muzio, Prof.

Conditions: Oligometastatic Disease, SBRT, Simultaneous Integrated Boost, Bone Metastases