ID

32481

Description

TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01542931

Link

https://clinicaltrials.gov/show/NCT01542931

Keywords

Versions (1)
  1. 11/3/18 11/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Stage III Oral Cavity Squamous Cell Carcinoma NCT01542931

English

Eligibility Stage III Oral Cavity Squamous Cell Carcinoma NCT01542931

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent prior to any study activities
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age 18-75 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
Description

Squamous cell carcinoma of mouth | Squamous cell carcinoma of tongue | Squamous cell carcinoma of gingiva | Squamous cell carcinoma of buccal mucosa | Squamous cell carcinoma of floor of mouth | Squamous cell carcinoma of palate | Squamous cell carcinoma Retromolar region

Data type

boolean

Alias
UMLS CUI [1]
C0585362
UMLS CUI [2]
C0349566
UMLS CUI [3]
C0349567
UMLS CUI [4]
C0280299
UMLS CUI [5]
C0280300
UMLS CUI [6]
C0349568
UMLS CUI [7,1]
C0007137
UMLS CUI [7,2]
C4247023
clinical stage iii/iva (t1-2, n1-2, m0 or t3-4, n0-2, m0, uicc 2002), resectable lesions
Description

TNM clinical staging | Lesion Resectable

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1514888
karnofsky performance status (kps) > 60
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate hematologic function: white blood cell > 3,000/mm^3, hemoglobin > 8g/l, platelet count > 80,000/mm^3
Description

Hematologic function | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
hepatic function: alat/asat < 2.5 times the upper limit of normal (uln), bilirubin < 1.5 times uln
Description

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
renal function: serum creatinine < 1.5 x uln
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
life expectancy ≥ 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of distant metastatic disease and other cancers
Description

Distant metastasis | Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C1707251
surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
Description

Operative Surgical Procedures Primary tumor | Operative Surgical Procedures Lymph nodes | Exception Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0024204
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005558
previous radiotherapy for the primary tumor or lymph nodes
Description

Prior radiation therapy Primary tumor | Prior radiation therapy Lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0024204
prior chemotherapy or immunotherapy for the primary tumor
Description

Prior Chemotherapy Primary tumor | Prior Immunotherapy Primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0677930
other previous malignancy within 5 years
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
systematic diseases history of severe pulmonary or cardiac diseases
Description

Disease systematic | Lung diseases Severe | Heart Diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0220922
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
creatinine clearance < 30 ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
legal incapacity or limited legal capacity
Description

Legal capacity Lacking | Legal capacity Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
pregnancy (confirmed by serum or urine β-hcg) or lactation period
Description

Pregnancy | Serum pregnancy test (B-HCG) | Choriogonadotropin.beta subunit (pregnancy test) Urine | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430060
UMLS CUI [3]
C2964947
UMLS CUI [4]
C0006147
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Similar models

Eligibility Stage III Oral Cavity Squamous Cell Carcinoma NCT01542931

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent prior to any study activities
boolean
C0021430 (UMLS CUI [1])
Age
Item
age 18-75 years old
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of mouth | Squamous cell carcinoma of tongue | Squamous cell carcinoma of gingiva | Squamous cell carcinoma of buccal mucosa | Squamous cell carcinoma of floor of mouth | Squamous cell carcinoma of palate | Squamous cell carcinoma Retromolar region
Item
histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
boolean
C0585362 (UMLS CUI [1])
C0349566 (UMLS CUI [2])
C0349567 (UMLS CUI [3])
C0280299 (UMLS CUI [4])
C0280300 (UMLS CUI [5])
C0349568 (UMLS CUI [6])
C0007137 (UMLS CUI [7,1])
C4247023 (UMLS CUI [7,2])
TNM clinical staging | Lesion Resectable
Item
clinical stage iii/iva (t1-2, n1-2, m0 or t3-4, n0-2, m0, uicc 2002), resectable lesions
boolean
C3258246 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
karnofsky performance status (kps) > 60
boolean
C0206065 (UMLS CUI [1])
Hematologic function | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement
Item
adequate hematologic function: white blood cell > 3,000/mm^3, hemoglobin > 8g/l, platelet count > 80,000/mm^3
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
hepatic function: alat/asat < 2.5 times the upper limit of normal (uln), bilirubin < 1.5 times uln
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
renal function: serum creatinine < 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Life Expectancy
Item
life expectancy ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis | Cancer Other
Item
evidence of distant metastatic disease and other cancers
boolean
C1269798 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
Operative Surgical Procedures Primary tumor | Operative Surgical Procedures Lymph nodes | Exception Biopsy
Item
surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
boolean
C0543467 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Prior radiation therapy Primary tumor | Prior radiation therapy Lymph nodes
Item
previous radiotherapy for the primary tumor or lymph nodes
boolean
C0279134 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
Prior Chemotherapy Primary tumor | Prior Immunotherapy Primary tumor
Item
prior chemotherapy or immunotherapy for the primary tumor
boolean
C1514457 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1514461 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
Cancer Other
Item
other previous malignancy within 5 years
boolean
C1707251 (UMLS CUI [1])
Disease systematic | Lung diseases Severe | Heart Diseases Severe
Item
systematic diseases history of severe pulmonary or cardiac diseases
boolean
C0012634 (UMLS CUI [1,1])
C0220922 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Creatinine clearance measurement
Item
creatinine clearance < 30 ml/min
boolean
C0373595 (UMLS CUI [1])
Legal capacity Lacking | Legal capacity Limited
Item
legal incapacity or limited legal capacity
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Pregnancy | Serum pregnancy test (B-HCG) | Choriogonadotropin.beta subunit (pregnancy test) Urine | Breast Feeding
Item
pregnancy (confirmed by serum or urine β-hcg) or lactation period
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2])
C2964947 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
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