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

Launched by ISTITUTO CLINICO HUMANITAS · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) to see how well it works and how safe it is for patients with oligometastatic disease caused by rare types of tumors. Oligometastatic disease means that cancer has spread beyond the original tumor but is still limited to a few sites in the body. The trial aims to find out if SBRT can provide better treatment options for these patients, as well as to understand if its effects vary between different types of rare tumors.

To be eligible for this study, participants should be between the ages of 65 and 74 and have a confirmed diagnosis of specific rare tumors, such as melanoma or soft tissue sarcoma. They should also be in good overall health, allowing them to participate. Participants can expect to receive SBRT treatment, which will focus on all active cancer spots in their body. The trial is not yet recruiting, so there will be no immediate participation, but it may offer new insights into managing these challenging cases in the future.

Gender

ALL

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