{
"info": {
"nct_id": "NCT01126476",
"official_title": "Retreatment of Recurrent Tumors Using Proton Therapy",
"inclusion_criteria": "* Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.\n* Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .\n* Age greater or equal to 18.\n* Patients must be able to provide informed consent.\n* Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)\n* Hysterectomy or menopause must be clinically documented.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.\n* Pregnant women, women planning to become pregnant and women that are nursing.\n* Actively being treated on any research study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.",
"criterions": [
{
"exact_snippets": "histologically confirmed, non-CNS solid malignancies",
"criterion": "non-CNS solid malignancies",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "previously radiated",
"criterion": "prior radiation treatment",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "tumor recurrence in or near prior radiation fields",
"criterion": "tumor recurrence location",
"requirement": {
"requirement_type": "location",
"expected_value": "in or near prior radiation fields"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "histologically confirmed, non-CNS solid malignancies",
"criterion": "non-CNS solid malignancies",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "previously radiated",
"criterion": "prior radiation treatment",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "tumor recurrence in or near prior radiation fields",
"criterion": "tumor recurrence location",
"requirement": {
"requirement_type": "location",
"expected_value": "in or near prior radiation fields"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Status of 60",
"criterion": "Karnofsky Performance Status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 60,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Life expectancy of 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky Performance Status of 60",
"criterion": "Karnofsky Performance Status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 60,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Life expectancy of 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Age greater or equal to 18.",
"criterions": [
{
"exact_snippets": "Age greater or equal to 18.",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age greater or equal to 18.",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must be able to provide informed consent.",
"criterions": [
{
"exact_snippets": "Patients must be able to provide informed consent.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients must be able to provide informed consent.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)",
"criterions": [
{
"exact_snippets": "Women of child bearing potential",
"criterion": "child bearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "agrees to use a recognized method of birth control",
"criterion": "use of birth control",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women of child bearing potential",
"criterion": "child bearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "agrees to use a recognized method of birth control",
"criterion": "use of birth control",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Hysterectomy or menopause must be clinically documented.",
"criterions": [
{
"exact_snippets": "Hysterectomy ... must be clinically documented.",
"criterion": "hysterectomy",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
},
{
"exact_snippets": "menopause must be clinically documented.",
"criterion": "menopause",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Hysterectomy ... must be clinically documented.",
"criterion": "hysterectomy",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
},
{
"exact_snippets": "menopause must be clinically documented.",
"criterion": "menopause",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.",
"criterions": [
{
"exact_snippets": "Prior radiation treatment less than 3 months from planned start of re-irradiation",
"criterion": "prior radiation treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior radiation treatment less than 3 months from planned start of re-irradiation",
"criterion": "prior radiation treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant women, women planning to become pregnant and women that are nursing.",
"criterions": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "status",
"expected_value": "pregnant"
}
},
{
"exact_snippets": "women planning to become pregnant",
"criterion": "pregnancy intention",
"requirement": {
"requirement_type": "intention",
"expected_value": "planning to become pregnant"
}
},
{
"exact_snippets": "women that are nursing",
"criterion": "nursing status",
"requirement": {
"requirement_type": "status",
"expected_value": "nursing"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "status",
"expected_value": "pregnant"
}
},
{
"exact_snippets": "women planning to become pregnant",
"criterion": "pregnancy intention",
"requirement": {
"requirement_type": "intention",
"expected_value": "planning to become pregnant"
}
},
{
"exact_snippets": "women that are nursing",
"criterion": "nursing status",
"requirement": {
"requirement_type": "status",
"expected_value": "nursing"
}
}
]
}
},
{
"identified_line": {
"line": "* Actively being treated on any research study.",
"criterions": [
{
"exact_snippets": "Actively being treated on any research study.",
"criterion": "treatment on research study",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Actively being treated on any research study.",
"criterion": "treatment on research study",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}