NCT05903261 Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors
| NCT ID | NCT05903261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Oligometastatic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-06-09 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-06-09 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05903261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oligometastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05903261 currently recruiting?
Yes, NCT05903261 is actively recruiting participants. Contact the research team at marta.scorsetti@hunimed.eu for enrollment information.
Where is the NCT05903261 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT05903261 clinical trial?
NCT05903261 is sponsored by Istituto Clinico Humanitas. The trial plans to enroll 200 participants.