Comparing two radiation therapies for treating bone metastases in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: dimuzio.nadia@hsr.it
• Phone: +390226437643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Immediate simulation-free SBRT for people with up to five metastatic tumors

  This tests whether giving stereotactic body radiation therapy (SBRT) right away without a separate CT simulation helps people with up to five metastatic cancer spots get treatment faster.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio · NCT07079098

• Stereotactic ablative radiotherapy versus single‑fraction palliative radiotherapy for oligoprogressive metastatic cancer

  This trial will test whether stereotactic ablative radiotherapy (SABR) works better than single‑fraction palliative radiotherapy (8 Gy) for people with 1–5 oligoprogressive metastatic lesions to delay the need for next‑line systemic therapy and improve quality of life.

  Recruiting British Columbia Cancer Agency · Surrey, British Columbia · NCT06918951

• Chemoimmunotherapy followed by surgery for limited spread esophageal and gastric cancer

  This study is testing if a combination of chemotherapy, immunotherapy, and surgery can help people with a limited spread of esophageal or gastric cancer live longer and have fewer recurrences.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT06668454

• Combining radiotherapy with systemic therapy for oligometastatic ureter cancer

  This study tests if adding radiotherapy to standard treatment can help people with a limited number of metastatic ureter cancer spots feel better and live longer.

  Recruiting at 2 sites Peking University First Hospital · Beijing and 1 other locations · NCT06652022

• Stereotactic radiotherapy for patients with oligometastatic cancer

  This study tests whether a special type of targeted radiation therapy can help people with a few metastatic tumors feel better compared to standard care after chemotherapy.

  Recruiting Phase 2/3 National Medical Research Radiological Centre of the Ministry of Health of Russia · Obninsk, Kaluga Oblast · NCT06556550

• Single‑fraction versus multiple‑fraction SBRT for treating limited metastases (SPRINT)

  This trial will test whether a single high‑dose SBRT treatment works as safely and effectively as multiple smaller SBRT treatments for people with limited metastases from breast, prostate, lung, or colorectal cancer.

  Recruiting at 2 sites European Organisation for Research and Treatment of Cancer - EORTC · Aalst and 14 other locations · NCT06462963

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.