{
"info": {
"nct_id": "NCT00006994",
"official_title": "S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Newly diagnosed, previously untreated squamous cell cancer of the oral cavity or oropharynx (T1-T4, any N, M0)\n* Must be scheduled to receive high-dose radiotherapy\n* Not concurrently receiving or planning to receive treatment on any other Southwest Oncology Group protocol\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 90\n\nPerformance status:\n\n* Zubrod 0-2\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* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n* Concurrent cisplatin, carboplatin, or fluorouracil allowed\n* No other concurrent chemotherapy during study and for at least 3 weeks after study radiotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent amifostine during and for 2 weeks after study radiotherapy"
},
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}
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}
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},
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}
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{
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}
},
{
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},
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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": "Other:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
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"requirement_type": "status",
"expected_value": "fertile"
}
},
{
"exact_snippets": "must use effective contraception",
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"requirement_type": "necessity",
"expected_value": true
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY:",
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{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
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}
}
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{
"identified_line": {
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{
"identified_line": {
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{
"identified_line": {
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{
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"fluorouracil"
]
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{
"exact_snippets": "Concurrent cisplatin, carboplatin, or fluorouracil allowed",
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}
},
{
"exact_snippets": "Concurrent cisplatin, carboplatin, or fluorouracil allowed",
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}
}
]
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}
]
}