{
"info": {
"nct_id": "NCT06103682",
"official_title": "LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)",
"inclusion_criteria": "1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:\n\n 1. Cohort A: Non-small cell cancer\n 2. Cohort B: Small cell cancer\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. [Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:",
"criterions": [
{
"exact_snippets": "Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies",
"criterion": "genitourinary malignancies",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": [
"histologically",
"biochemically"
]
}
]
}
]
},
{
"line": "1. Cohort A: Non-small cell cancer",
"criterions": [
{
"exact_snippets": "Non-small cell cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "non-small cell"
}
]
}
]
},
{
"line": "2. Cohort B: Small cell cancer",
"criterions": [
{
"exact_snippets": "Small cell cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "small cell"
}
]
}
]
},
{
"line": "2. Provision of signed and dated informed consent form.",
"criterions": [
{
"exact_snippets": "Provision of signed and dated informed consent form.",
"criterion": "informed consent form",
"requirements": [
{
"requirement_type": "provision",
"expected_value": true
},
{
"requirement_type": "signed",
"expected_value": true
},
{
"requirement_type": "dated",
"expected_value": true
}
]
}
]
},
{
"line": "3. Stated willingness to comply with all study procedures and availability for the duration of the study.",
"criterions": [
{
"exact_snippets": "Stated willingness to comply with all study procedures",
"criterion": "willingness to comply with study procedures",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "availability for the duration of the study",
"criterion": "availability for the duration of the study",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "4. Age ≥18 years at time of consent.",
"criterions": [
{
"exact_snippets": "Age ≥18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.",
"criterions": [
{
"exact_snippets": "Currently on systemic therapy",
"criterion": "systemic therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "a candidate to continue their current line of systemic therapy",
"criterion": "continuation of systemic therapy",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
},
{
"exact_snippets": "no more than a planned 30-day break",
"criterion": "planned break from systemic therapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
]
}
]
},
{
"line": "6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. [Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment]",
"criterions": [
{
"exact_snippets": "≥ 1 line of systemic therapy for metastatic disease",
"criterion": "systemic therapy for metastatic disease",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "line"
}
}
]
},
{
"exact_snippets": "≥ 3 months of clinical benefit on most recent line of systemic therapy",
"criterion": "clinical benefit on most recent line of systemic therapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "prior to the development of new metastatic lesions",
"criterion": "development of new metastatic lesions",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "prior"
}
]
},
{
"exact_snippets": "Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment",
"criterion": "tumor burden stability",
"requirements": [
{
"requirement_type": "stability",
"expected_value": true
}
]
},
{
"exact_snippets": "not requiring an immediate change in systemic treatment",
"criterion": "immediate change in systemic treatment",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
}
]
}
]
},
{
"line": "7. ≤ 5 progressing or new metastatic lesions.",
"criterions": [
{
"exact_snippets": "≤ 5 progressing or new metastatic lesions",
"criterion": "metastatic lesions",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "N/A"
}
},
{
"requirement_type": "status",
"expected_value": [
"progressing",
"new"
]
}
]
}
]
},
{
"line": "8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.",
"criterions": [
{
"exact_snippets": "All progressing or new metastatic lesions",
"criterion": "metastatic lesions",
"requirements": [
{
"requirement_type": "progression",
"expected_value": [
"progressing",
"new"
]
}
]
},
{
"exact_snippets": "can be safely treated with locally ablative therapies",
"criterion": "treatability with locally ablative therapies",
"requirements": [
{
"requirement_type": "safety",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Medical comorbidities precluding locally ablative therapies.",
"criterions": [
{
"exact_snippets": "Medical comorbidities precluding locally ablative therapies",
"criterion": "medical comorbidities",
"requirements": [
{
"requirement_type": "impact on treatment",
"expected_value": "precluding locally ablative therapies"
}
]
}
]
},
{
"line": "2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.",
"criterions": [
{
"exact_snippets": "History of treatment related toxicities that limit or prohibit application of locally ablative therapies.",
"criterion": "treatment related toxicities",
"requirements": [
{
"requirement_type": "impact",
"expected_value": "limit or prohibit application of locally ablative therapies"
}
]
}
]
},
{
"line": "3. Progressing intracranial lesions.",
"criterions": [
{
"exact_snippets": "Progressing intracranial lesions",
"criterion": "intracranial lesions",
"requirements": [
{
"requirement_type": "progression",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}