Comparison of One-Time Radiosurgery Versus Five-Day Stereotactic Radiotherapy with Boost for Treating Bone Metastases in Oligometastatic Cancer
Led by IRCCS San Raffaele · Updated on 2025-06-11
307
Participants Needed
1
Research Sites
108 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating two types of stereotactic ablative radiotherapy for treating bone metastases in patients with oligometastatic cancer, where cancer has spread to a limited number of sites. This randomized, prospective study conducted at a single institution compares radiosurgery delivered in one high-dose fraction to a five-fraction stereotactic radiotherapy with a simultaneous integrated boost SIB. The study aims to understand which approach better controls local disease while monitoring safety and quality of life outcomes over three years.
Participants are randomly assigned to one of two treatment groups Arm A receives a single fraction of radiosurgery delivering 21-24 Gy to bone metastases, while Arm B receives five daily fractions of stereotactic ablative radiotherapy with an SIB delivering up to 40-50 Gy. The treatments begin within 15 days after simulation CT and are completed within 45 days from randomization. Both treatment methods are part of routine clinical practice in specialized centers.
During the study, patients will be assessed through clinical visits at the end of treatment and at 3, 6, 12, 18, 24, and 36 months afterward. These visits include imaging tests such as CT, bone scans, MRI, or PETCT depending on tumor location and history, along with physical exams and laboratory tests. Researchers will monitor local recurrence-free survival, toxicity, pain control, overall survival, disease progression, and quality of life using standardized questionnaires and pain diaries. Follow-ups occur in the radiation oncology department to ensure comprehensive monitoring of treatment effects and safety.
CONDITIONS
Brief Title
Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions
Research Team
N
Nadia G Di Muzio, Prof.
A
Andrei Fodor, MD
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Evidence of spinal cord compression or tumor within 2 mm of spinal cord
Vertebral body fracture or over 40% vertebral body involvement
Cortical involvement in long bones
Pregnant or breastfeeding women
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Pre-treatment
Duration - Up to 15 days from randomization
Participants undergo simulation CT and MRI scans with immobilization devices as part of routine preparation for radiotherapy treatment.
1 to 2 visits (in-person)
Treatment
Duration - 1 to 5 consecutive days within 1 month from simulation CT
Participants receive either single-fraction radiosurgery or multifraction stereotactic ablative radiotherapy with simultaneous integrated boost for bone metastases.
1 visit for single-fraction radiosurgery OR 5 daily visits for stereotactic radiotherapy
Follow-up
Duration - Up to 36 months from end of treatment
Participants attend follow-up visits to monitor treatment effects, toxicity, pain control, and overall health with imaging and laboratory tests as needed.
Visits at 3, 6, 12, 18, 24, and 36 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Prognostic factors and a scoring system for survival after radiotherapy for metastases to the spinal column: a review of 544 patients at Shizuoka Cancer Center Hospital.
Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation.
Matthias Guckenberger, Yolande Lievens, Angelique B Bouma...
Radiosurgery and fractionated stereotactic radiotherapy in oligometastatic/oligoprogressive non-small cell lung cancer patients: Results of a multi-institutional series of 198 patients treated with "curative" intent.
Michela Buglione, Barbara Alicja Jereczek-Fossa, Marco Lorenzo Bonù...
Safety and Survival Rates Associated With Ablative Stereotactic Radiotherapy for Patients With Oligometastatic Cancer: A Systematic Review and Meta-analysis.