Clinical Trials in Italy / NCT05903261
Recruiting Observational

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

NCT05903261 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-06-09
Last updated
2025-04-25

Condition(s) studied

Oligometastatic Disease

Investigational drug(s) / intervention(s)

SBRT

SBRT: stereotactic body radiation therapy (SBRT)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * prior treatment with radiation to the same metastatic site * inability to provide informed consent * contraindications to SBRT

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano Milan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05903261 on ClinicalTrials.gov ↗ ← All trials in Italy