Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions

Launched by IRCCS SAN RAFFAELE · Dec 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of radiation therapy to treat bone metastases in patients with oligometastatic cancer, which means they have a limited number of cancer spread areas (between 1 to 5) and it hasn't spread widely. The trial compares ablative radiosurgery, which delivers a high dose of radiation in one session, to stereotactic radiotherapy, which gives a lower dose over five sessions with a special technique that targets the cancer more precisely. The goal is to see which method is more effective in treating these specific types of cancer spread.

To participate in this study, patients should be between 65 and 74 years old and have a good performance status, meaning they can carry out daily activities with minimal issues. They must have a life expectancy of more than six months and at least one bone metastasis that can be treated with the study's radiation methods. Certain health conditions or specific characteristics of their cancer may prevent them from joining. If eligible, participants can expect to receive either of the radiation treatments and will be monitored for one year to evaluate the results. This study is currently recruiting participants, and the findings could help shape future cancer treatment options.

Gender

ALL

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