Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors
Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors: the PROMPT Study
Istituto Clinico Humanitas
200 participants
Jun 9, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria3
- prior treatment with radiation to the same metastatic site
- inability to provide informed consent
- contraindications to SBRT
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Interventions
stereotactic body radiation therapy (SBRT)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05903261