Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors

Recruiting now

Conditions studied: Oligometastatic Disease

In brief

This prospective observational study aims to investigate the effectiveness and safety of SBRT in the management of oligometastases from rare tumors. In addition, the study aims to identify potential differences in treatment efficacy and toxicity between different types of cancer and to provide valuable information on the use of SBRT in these contexts, potentially leading to better treatment options and outcomes for these patients.

Key facts

Study ID

NCT05903261

Run by

Istituto Clinico Humanitas

People needed

200

Starts

2023-06-09

Expected to finish

2026-06-01

Last updated by the study team

2025-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG PS 0 - 2
• histologically confirmed diagnosis of rare solid tumors including melanoma, soft tissue sarcoma, head-neck tumors, gynaecological tumors, Merkel cell carcinoma, thymic carcinoma, gastrointestinal stromal tumors (GIST) and urothelial tumors
• No limit to the number of metastases treated with SBRT but all active lesions must be treated with radical intent (primary tumor and metastases)
• Synchronous and metachronous oligometastases, as well as oligorecurrent and oligoprogressive disease are allowed
• Ablative dose intended as a minimum dose of 50Gy EQD2/10 in a maximum of 10 fractions
• No restrictions to prior or on-going systemic therapies

You may not qualify if…

• prior treatment with radiation to the same metastatic site
• inability to provide informed consent
• contraindications to SBRT

Where it is running

• Humanitas Research Hospital — Rozzano, Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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