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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

prior treatment with radiation to the same metastatic site

inability to provide informed consent

contraindications to SBRT

Trial population

Patients who underwent stereotactic body radiation therapy (SBRT) for oligometastases from 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SBRT

    Radiation

    stereotactic body radiation therapy (SBRT)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

local control of treated metastases at 2 years after SBRT

local control of treated metastases at 2 years after SBRT

Time frame
2 years

Secondary outcomes

1

overall survival

overall survival

Time frame
2 years
2

progression-free survival

time for which the patient has no trace oligometastatic progression

Time frame
2 years
3

distant control

analyze the formation of new metastases distant from the oligometastatic site

Time frame
2 years
4

toxicity rates

toxicity values caused by SBRT

Time frame
2 years

Other outcomes

Sponsors and contacts

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