{
"info": {
"nct_id": "NCT02867865",
"official_title": "Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers",
"inclusion_criteria": "Locally advanced T3 or T4 tumors with one or more of the following:\n\n-> 2 cm but < 5 cm liver invasion\n\n* Radiological involvement of antropyloric region of stomach, duodenum, hepatic flexure of colon or small intestine, but without infiltration of the mucosa on endoscopy.\n* Type I/II invasion -Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) causing obstructive jaundice\n* Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal (Station 13) i.e. size>1cm in short axis, round in shape, and heterogenous enhancement on PET scan.\n* Vascular involvement : impingement/ involvement (<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein (stage III disease)\n* Patient who have undergone prior cholecystectomy having residual disease with at least one of the above features.\n* Biopsy/ cytology proven adenocarcinoma\n* More than 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Normal hematological and renal and hepatic functions (serum bilirubin < 3mg/dl)\nHealthy volunteers allowed\nMust have minimum age of 19 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Resectable disease\n* Evidence of distant metastasis (Liver, Lung, peritoneum, port site etc)\n* Involving major part of the liver precluding restriction of full RT doses\n* Received any prior radiation or chemotherapy.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "Locally advanced T3 or T4 tumors with one or more of the following:",
"criterions": [
{
"exact_snippets": "Locally advanced T3 or T4 tumors",
"criterion": "tumor stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"T3",
"T4"
]
}
},
{
"exact_snippets": "Locally advanced T3 or T4 tumors",
"criterion": "tumor stage",
"requirement": {
"requirement_type": "local advancement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Locally advanced T3 or T4 tumors",
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"requirement": {
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"expected_value": [
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]
}
},
{
"exact_snippets": "Locally advanced T3 or T4 tumors",
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"requirement": {
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"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "-> 2 cm but < 5 cm liver invasion",
"criterions": [
{
"exact_snippets": "2 cm but < 5 cm liver invasion",
"criterion": "liver invasion",
"requirement": {
"requirement_type": "size",
"expected_value": {
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{
"operator": ">=",
"value": 2,
"unit": "cm"
},
{
"operator": "<",
"value": 5,
"unit": "cm"
}
]
}
}
}
]
},
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{
"exact_snippets": "2 cm but < 5 cm liver invasion",
"criterion": "liver invasion",
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"operator": ">=",
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"unit": "cm"
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"criterions": [
{
"exact_snippets": "Radiological involvement of antropyloric region of stomach",
"criterion": "radiological involvement of antropyloric region of stomach",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Radiological involvement of ... duodenum",
"criterion": "radiological involvement of duodenum",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Radiological involvement of ... hepatic flexure of colon",
"criterion": "radiological involvement of hepatic flexure of colon",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Radiological involvement of ... small intestine",
"criterion": "radiological involvement of small intestine",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "without infiltration of the mucosa on endoscopy",
"criterion": "infiltration of the mucosa on endoscopy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
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"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
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"exact_snippets": "Radiological involvement of antropyloric region of stomach",
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"expected_value": true
}
},
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"criterion": "radiological involvement of duodenum",
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{
"exact_snippets": "without infiltration of the mucosa on endoscopy",
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"requirement": {
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"expected_value": false
}
}
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},
{
"and_criteria": [
{
"exact_snippets": "Radiological involvement of ... hepatic flexure of colon",
"criterion": "radiological involvement of hepatic flexure of colon",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "without infiltration of the mucosa on endoscopy",
"criterion": "infiltration of the mucosa on endoscopy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Radiological involvement of ... small intestine",
"criterion": "radiological involvement of small intestine",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "without infiltration of the mucosa on endoscopy",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
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},
{
"identified_line": {
"line": "* Type I/II invasion -Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) causing obstructive jaundice",
"criterions": [
{
"exact_snippets": "Type I/II invasion",
"criterion": "invasion type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Type I",
"Type II"
]
}
},
{
"exact_snippets": "Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct)",
"criterion": "bile duct involvement",
"requirement": {
"requirement_type": "location",
"expected_value": [
"common hepatic duct",
"proximal 1/3 of the common bile duct"
]
}
},
{
"exact_snippets": "causing obstructive jaundice",
"criterion": "obstructive jaundice",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Type I/II invasion",
"criterion": "invasion type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"Type I",
"Type II"
]
}
},
{
"exact_snippets": "Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct)",
"criterion": "bile duct involvement",
"requirement": {
"requirement_type": "location",
"expected_value": [
"common hepatic duct",
"proximal 1/3 of the common bile duct"
]
}
}
]
},
{
"exact_snippets": "causing obstructive jaundice",
"criterion": "obstructive jaundice",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal (Station 13) i.e. size>1cm in short axis, round in shape, and heterogenous enhancement on PET scan.",
"criterions": [
{
"exact_snippets": "Radiological suspicion of lymph node involvement N1",
"criterion": "lymph node involvement",
"requirement": {
"requirement_type": "suspicion",
"expected_value": true
}
},
{
"exact_snippets": "size>1cm in short axis",
"criterion": "lymph node size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "round in shape",
"criterion": "lymph node shape",
"requirement": {
"requirement_type": "shape",
"expected_value": "round"
}
},
{
"exact_snippets": "heterogenous enhancement on PET scan",
"criterion": "lymph node enhancement",
"requirement": {
"requirement_type": "enhancement",
"expected_value": "heterogenous"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Radiological suspicion of lymph node involvement N1",
"criterion": "lymph node involvement",
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"expected_value": true
}
},
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"exact_snippets": "size>1cm in short axis",
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"unit": "cm"
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}
}
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"exact_snippets": "heterogenous enhancement on PET scan",
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}
}
]
}
},
{
"identified_line": {
"line": "* Patient who have undergone prior cholecystectomy having residual disease with at least one of the above features.",
"criterions": [
{
"exact_snippets": "undergone prior cholecystectomy",
"criterion": "prior cholecystectomy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "having residual disease",
"criterion": "residual disease",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "at least one of the above features",
"criterion": "above features",
"requirement": {
"requirement_type": "quantity",
"expected_value": ">= 1"
}
}
]
},
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"exact_snippets": "undergone prior cholecystectomy",
"criterion": "prior cholecystectomy",
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"expected_value": true
}
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"exact_snippets": "having residual disease",
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"requirement": {
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}
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"exact_snippets": "at least one of the above features",
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}
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}
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"identified_line": {
"line": "* Biopsy/ cytology proven adenocarcinoma",
"criterions": [
{
"exact_snippets": "Biopsy/ cytology proven adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
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"expected_value": [
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]
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Biopsy/ cytology proven adenocarcinoma",
"criterion": "adenocarcinoma",
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"requirement_type": "confirmation method",
"expected_value": [
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"cytology"
]
}
}
]
}
},
{
"identified_line": {
"line": "* More than 18 years of age",
"criterions": [
{
"exact_snippets": "More than 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
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"exact_snippets": "More than 18 years of age",
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"operator": ">",
"value": 18,
"unit": "years"
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}
}
]
}
},
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"identified_line": {
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{
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}
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"criterion": "hematological functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal ... renal ... functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal ... hepatic functions",
"criterion": "hepatic functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "serum bilirubin < 3mg/dl",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "mg/dl"
}
}
}
]
},
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{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
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"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
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]
}
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"exact_snippets": "Normal hematological ... functions",
"criterion": "hematological functions",
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"expected_value": "normal"
}
}
]
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{
"exact_snippets": "Normal ... renal ... functions",
"criterion": "renal functions",
"requirement": {
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}
}
]
},
{
"exact_snippets": "Normal ... hepatic functions",
"criterion": "hepatic functions",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
{
"exact_snippets": "serum bilirubin < 3mg/dl",
"criterion": "serum bilirubin",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 3,
"unit": "mg/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
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"exact_snippets": "Healthy volunteers allowed",
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 19 Years",
"criterions": [
{
"exact_snippets": "minimum age of 19 Years",
"criterion": "age",
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"operator": ">=",
"value": 19,
"unit": "Years"
}
}
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"exact_snippets": "minimum age of 19 Years",
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"unit": "Years"
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}
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}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
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{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
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"value": 80,
"unit": "Years"
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}
}
]
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"value": 80,
"unit": "Years"
}
}
}
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}
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],
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"criterions": [
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"criterion": "disease resectability",
"requirement": {
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"expected_value": true
}
}
]
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"expected_value": true
}
}
}
},
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"requirement": {
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"expected_value": true
}
}
]
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"expected_value": true
}
}
}
},
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"identified_line": {
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{
"exact_snippets": "Involving major part of the liver",
"criterion": "liver involvement",
"requirement": {
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"expected_value": "major part"
}
},
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"exact_snippets": "precluding restriction of full RT doses",
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"expected_value": "major part"
}
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},
{
"identified_line": {
"line": "* Received any prior radiation or chemotherapy.",
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{
"exact_snippets": "Received any prior radiation",
"criterion": "prior radiation",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Received any prior ... chemotherapy",
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"requirement": {
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"expected_value": true
}
}
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"expected_value": true
}
},
{
"exact_snippets": "Received any prior ... chemotherapy",
"criterion": "prior chemotherapy",
"requirement": {
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"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Vascular involvement : impingement/ involvement (<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein (stage III disease)",
"criterions": [
{
"exact_snippets": "Vascular involvement : impingement/ involvement (<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein",
"criterion": "vascular involvement",
"requirement": {
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"operator": "<",
"value": 180,
"unit": "degree angle"
}
}
},
{
"exact_snippets": "Vascular involvement : impingement/ involvement (<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein",
"criterion": "vascular involvement",
"requirement": {
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]
}
},
{
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"criterion": "disease stage",
"requirement": {
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}
}
]
},
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}