ID

23171

Beskrivning

Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil; ODM derived from: https://clinicaltrials.gov/show/NCT00400205

Länk

https://clinicaltrials.gov/show/NCT00400205

Nyckelord

Versioner (1)
  1. 26/06/17 26/06/17 -
Uppladdad den

26 giugno 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT00400205

Engelsk

Eligibility Squamous Cell Carcinoma NCT00400205

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven squamous cell carcinoma of the oral cavity.
Beskrivning

Squamous cell carcinoma of mouth

Datatyp

boolean

Alias
UMLS CUI [1]
C0585362
primary tumor sites eligible: oral cavity. although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
Beskrivning

Primary tumor site Oral cavity | Chemotherapy | Neoplasm of nasal cavity Excluded | Nasal sinus Neoplasms Excluded | Nasopharyngeal Neoplasms Excluded | Mouth Neoplasms Associated with Mandible Invasion | Excision Probably

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475447
UMLS CUI [1,2]
C0226896
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0345630
UMLS CUI [3,2]
C2828389
UMLS CUI [4,1]
C0030471
UMLS CUI [4,2]
C0027651
UMLS CUI [4,3]
C2828389
UMLS CUI [5,1]
C0027439
UMLS CUI [5,2]
C2828389
UMLS CUI [6,1]
C0026640
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0024687
UMLS CUI [6,4]
C1269955
UMLS CUI [7,1]
C0728940
UMLS CUI [7,2]
C0750492
stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or ct scan (liver function test abnormalities); bone scan in case of local symptoms.
Beskrivning

Disease TNM clinical staging | Distant metastasis Absent Plain chest X-ray | Distant metastasis Absent Ultrasonography of abdomen | Liver function tests abnormal X-Ray Computed Tomography | Symptoms Local Bone scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1302548
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0039985
UMLS CUI [3,1]
C1302548
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0203464
UMLS CUI [4,1]
C0151766
UMLS CUI [4,2]
C0040405
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0205276
UMLS CUI [5,3]
C0203668
at least one uni- or bi-dimensionally measurable lesion.
Beskrivning

Measurable lesion Linear Quantity | Measurable lesion 2-Dimensional Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [2,3]
C1265611
age ≥ 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
who (world health organization)performance status of 2 or less.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
no active alcohol addiction.
Beskrivning

Chronic Alcoholic Intoxication Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0332197
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Beskrivning

Clinical Trial Eligibility Criteria Determination Final

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0013893
UMLS CUI [1,3]
C3853528
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
Beskrivning

Malignant Neoplasms Site Other | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Curative Surgery Malignant Neoplasms | Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C1511562
UMLS CUI [5,2]
C0006826
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0332296
any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
Beskrivning

Therapeutic radiology procedure | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
Beskrivning

Weight decreased Involuntary Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C2986385
UMLS CUI [1,3]
C0439165
concurrent treatment with any other anti-cancer therapy.
Beskrivning

cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
participation in an investigational trial within 30 days of study entry.
Beskrivning

Participation Clinical Trial Investigational

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1517586
patients with a history of severe hypersensitivity reaction to taxotere® or other drugs formulated with polysorbate 80.
Beskrivning

Hypersensitivity Severe Taxotere | Hypersensitivity Severe Polysorbate 80 Drug Formulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0699967
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0032601
UMLS CUI [2,4]
C0524527
no previous chemotherapy or radiotherapy for any reason and no previous surgery for scchn [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed at the time of study entry.
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures Squamous cell carcinoma of the head and neck | Biopsy Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1168401
UMLS CUI [4,1]
C0005558
UMLS CUI [4,2]
C2828389
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Beskrivning

Clinical Trial Eligibility Criteria Determination Final

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0013893
UMLS CUI [1,3]
C3853528
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Similar models

Eligibility Squamous Cell Carcinoma NCT00400205

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of mouth
Item
histologically or cytologically proven squamous cell carcinoma of the oral cavity.
boolean
C0585362 (UMLS CUI [1])
Primary tumor site Oral cavity | Chemotherapy | Neoplasm of nasal cavity Excluded | Nasal sinus Neoplasms Excluded | Nasopharyngeal Neoplasms Excluded | Mouth Neoplasms Associated with Mandible Invasion | Excision Probably
Item
primary tumor sites eligible: oral cavity. although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
boolean
C0475447 (UMLS CUI [1,1])
C0226896 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0345630 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0030471 (UMLS CUI [4,1])
C0027651 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C0027439 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
C0026640 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0024687 (UMLS CUI [6,3])
C1269955 (UMLS CUI [6,4])
C0728940 (UMLS CUI [7,1])
C0750492 (UMLS CUI [7,2])
Disease TNM clinical staging | Distant metastasis Absent Plain chest X-ray | Distant metastasis Absent Ultrasonography of abdomen | Liver function tests abnormal X-Ray Computed Tomography | Symptoms Local Bone scan
Item
stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or ct scan (liver function test abnormalities); bone scan in case of local symptoms.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1302548 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0039985 (UMLS CUI [2,3])
C1302548 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0203464 (UMLS CUI [3,3])
C0151766 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0205276 (UMLS CUI [5,2])
C0203668 (UMLS CUI [5,3])
Measurable lesion Linear Quantity | Measurable lesion 2-Dimensional Quantity
Item
at least one uni- or bi-dimensionally measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who (world health organization)performance status of 2 or less.
boolean
C1298650 (UMLS CUI [1])
Chronic Alcoholic Intoxication Absent
Item
no active alcohol addiction.
boolean
C0001973 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Determination Final
Item
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
boolean
C1516637 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C3853528 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Site Other | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Curative Surgery Malignant Neoplasms | Disease Free of
Item
previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0851140 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C1511562 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
Therapeutic radiology procedure | Chemotherapy
Item
any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Weight decreased Involuntary Percentage
Item
patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
boolean
C1262477 (UMLS CUI [1,1])
C2986385 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
cancer treatment
Item
concurrent treatment with any other anti-cancer therapy.
boolean
C0920425 (UMLS CUI [1])
Participation Clinical Trial Investigational
Item
participation in an investigational trial within 30 days of study entry.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
Hypersensitivity Severe Taxotere | Hypersensitivity Severe Polysorbate 80 Drug Formulation
Item
patients with a history of severe hypersensitivity reaction to taxotere® or other drugs formulated with polysorbate 80.
boolean
C0020517 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0699967 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0032601 (UMLS CUI [2,3])
C0524527 (UMLS CUI [2,4])
Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures Squamous cell carcinoma of the head and neck | Biopsy Excluded
Item
no previous chemotherapy or radiotherapy for any reason and no previous surgery for scchn [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed at the time of study entry.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C1168401 (UMLS CUI [3,2])
C0005558 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Clinical Trial Eligibility Criteria Determination Final
Item
final eligibility for a clinical trial is determined by the health professionals conducting the trial.
boolean
C1516637 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C3853528 (UMLS CUI [1,3])
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