{
"info": {
"nct_id": "NCT00080782",
"official_title": "A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust be MALE",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of androgen-independent prostate cancer\n\n * Osteoblastic metastases\n * No predominant visceral metastases\n* Progressive disease after response to prior induction chemotherapy (prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment)\n* No symptomatic lymphadenopathy (i.e., scrotal or pedal edema)\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Any age\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Adequate physiologic reserves\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radionuclide therapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No more than 3 prior cytotoxic treatments\n* More than 6 months since prior celecoxib or rofecoxib"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "healthy volunteers",
"requirement": {
"requirement_type": "participation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "healthy volunteers",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
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{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Diagnosis of androgen-independent prostate cancer",
"criterions": [
{
"exact_snippets": "Diagnosis of androgen-independent prostate cancer",
"criterion": "androgen-independent prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of androgen-independent prostate cancer",
"criterion": "androgen-independent prostate cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Osteoblastic metastases",
"criterions": [
{
"exact_snippets": "Osteoblastic metastases",
"criterion": "osteoblastic metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Osteoblastic metastases",
"criterion": "osteoblastic metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No predominant visceral metastases",
"criterions": [
{
"exact_snippets": "No predominant visceral metastases",
"criterion": "visceral metastases",
"requirement": {
"requirement_type": "predominance",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No predominant visceral metastases",
"criterion": "visceral metastases",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Progressive disease after response to prior induction chemotherapy (prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment)",
"criterions": [
{
"exact_snippets": "Progressive disease after response to prior induction chemotherapy",
"criterion": "progressive disease",
"requirement": {
"requirement_type": "temporal",
"expected_value": "after response to prior induction chemotherapy"
}
},
{
"exact_snippets": "prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment",
"criterion": "prostate-specific antigen decline",
"requirement": {
"requirement_type": "percentage decline",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment",
"criterion": "prostate-specific antigen decline",
"requirement": {
"requirement_type": "temporal",
"expected_value": "after 16 weeks of treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Progressive disease after response to prior induction chemotherapy",
"criterion": "progressive disease",
"requirement": {
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"expected_value": "after response to prior induction chemotherapy"
}
},
{
"and_criteria": [
{
"exact_snippets": "prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment",
"criterion": "prostate-specific antigen decline",
"requirement": {
"requirement_type": "percentage decline",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment",
"criterion": "prostate-specific antigen decline",
"requirement": {
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"expected_value": "after 16 weeks of treatment"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* No symptomatic lymphadenopathy (i.e., scrotal or pedal edema)",
"criterions": [
{
"exact_snippets": "No symptomatic lymphadenopathy",
"criterion": "symptomatic lymphadenopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "scrotal or pedal edema",
"criterion": "scrotal edema",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "scrotal or pedal edema",
"criterion": "pedal edema",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No symptomatic lymphadenopathy",
"criterion": "symptomatic lymphadenopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"or_criteria": [
{
"exact_snippets": "scrotal or pedal edema",
"criterion": "scrotal edema",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "scrotal or pedal edema",
"criterion": "pedal edema",
"requirement": {
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"expected_value": false
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "Age",
"criterions": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Any age",
"criterions": [
{
"exact_snippets": "Any age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": []
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Any age",
"criterion": "age",
"requirement": {
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"expected_value": {
"comparisons": []
}
}
}
]
}
},
{
"identified_line": {
"line": "Performance status",
"criterions": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy",
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "Hematopoietic",
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{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic system",
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic system",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Hepatic",
"criterions": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Hepatic",
"criterion": "hepatic function",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Renal",
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"exact_snippets": "Renal",
"criterion": "renal function",
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Renal",
"criterion": "renal function",
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}
}
]
}
},
{
"identified_line": {
"line": "* Adequate physiologic reserves",
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{
"exact_snippets": "Adequate physiologic reserves",
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"expected_value": true
}
}
]
},
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{
"exact_snippets": "Adequate physiologic reserves",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
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{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
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"expected_value": true
}
}
]
},
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{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Biologic therapy",
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{
"exact_snippets": "Biologic therapy",
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}
}
]
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}
]
}
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}
]
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]
}
},
{
"identified_line": {
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}
}
]
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]
}
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{
"identified_line": {
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}
}
]
},
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"exact_snippets": "Endocrine therapy",
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}
]
}
},
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}
}
]
},
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"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
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}
]
}
},
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{
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}
}
]
},
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"exact_snippets": "Surgery",
"criterion": "surgery",
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}
}
]
}
},
{
"identified_line": {
"line": "* No more than 3 prior cytotoxic treatments",
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{
"exact_snippets": "No more than 3 prior cytotoxic treatments",
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"value": 3,
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}
}
}
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},
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"exact_snippets": "No more than 3 prior cytotoxic treatments",
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}
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "More than 6 months since prior celecoxib",
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"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "More than 6 months since prior ... rofecoxib",
"criterion": "rofecoxib usage",
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"operator": ">",
"value": 6,
"unit": "months"
}
}
}
]
},
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{
"exact_snippets": "More than 6 months since prior celecoxib",
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}
}
},
{
"exact_snippets": "More than 6 months since prior ... rofecoxib",
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"unit": "months"
}
}
}
]
}
},
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},
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}
},
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},
"logical_structure": {
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}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Other",
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},
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"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
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"criterions": []
},
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}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
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{
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}
}
]
},
"logical_structure": {
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}
}
}
}
]
}