{
"info": {
"nct_id": "NCT05857631",
"official_title": "Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study",
"inclusion_criteria": "1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n2. Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Patients with macroscopic residual disease (R+ resection) postoperatively\n2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)\n3. Patients treated with chemotherapy for any prior malignancy at any time\n4. Patients treated with pelvic radiation previously\n5. Patients with human immunodeficiency virus infection\n6. Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)",
"miscellaneous_criteria": ""
},
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"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
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"unit": "N/A"
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}
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{
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"unit": "Years"
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"unit": "Years"
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"line": "Must have maximum age of 80 Years",
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"exact_snippets": "maximum age of 80 Years",
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"unit": "Years"
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"value": 80,
"unit": "Years"
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"criterions": [
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"criterion": "cervical cancer diagnosis",
"requirement": {
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"expected_value": "histologically confirmed"
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{
"exact_snippets": "post hysterectomy",
"criterion": "hysterectomy status",
"requirement": {
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"expected_value": "post"
}
},
{
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"requirement": {
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]
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},
{
"exact_snippets": "requiring adjuvant EBRT ± concurrent chemotherapy",
"criterion": "adjuvant therapy requirement",
"requirement": {
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"expected_value": [
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"concurrent chemotherapy"
]
}
},
{
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"criterion": "endometrial cancer diagnosis",
"requirement": {
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{
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"requirement": {
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"expected_value": "post"
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{
"exact_snippets": "requiring adjuvant (chemo)radiotherapy to pelvis",
"criterion": "adjuvant therapy requirement",
"requirement": {
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"expected_value": "(chemo)radiotherapy to pelvis"
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},
{
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"requirement": {
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"criterion": "cervical cancer diagnosis",
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{
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"criterion": "endometrial cancer diagnosis",
"requirement": {
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"expected_value": "histologically confirmed"
}
},
{
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"criterion": "hysterectomy status",
"requirement": {
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{
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"criterion": "adjuvant therapy requirement",
"requirement": {
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}
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{
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]
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"exclusion_lines": [
{
"identified_line": {
"line": "1. Patients with macroscopic residual disease (R+ resection) postoperatively",
"criterions": [
{
"exact_snippets": "macroscopic residual disease (R+ resection)",
"criterion": "macroscopic residual disease",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
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"criterion": "macroscopic residual disease",
"requirement": {
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"expected_value": true
}
}
]
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},
{
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"criterions": [
{
"exact_snippets": "requiring extended field radiotherapy",
"criterion": "extended field radiotherapy",
"requirement": {
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"expected_value": true
}
},
{
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"requirement": {
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"expected_value": true
}
},
{
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"criterion": "cervical or endometrial cancer",
"requirement": {
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}
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"and_criteria": [
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}
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"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}