ID

43364

Description

ODM derived from http://clinicaltrials.gov/show/NCT00508664

Link

http://clinicaltrials.gov/show/NCT00508664

Keywords

Versions (3)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00005561 NCT00508664 Squamous Cell Carcinoma of the Hypopharynx

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
Description

Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0023065
SNOMED CT 2011_0131
72791001
MedDRA 14.1
10023872
ICD-9-CM Version 2011
30
UMLS CUI 2011AA
C0007137
SNOMED CT 2011_0131
28899001
MedDRA 14.1
10041823
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0023078
SNOMED CT 2011_0131
4596009
LOINC Version 232
MTHU015048
UMLS CUI 2011AA
C0020629
SNOMED CT 2011_0131
81502006
T3-T4a carcinoma of the glottis
Description

T3-T4a carcinoma of the glottis

Data type

boolean

Alias
UMLS CUI 2011AA
C0475374
SNOMED CT 2011_0131
14410001
UMLS CUI 2011AA
C0475751
SNOMED CT 2011_0131
65565005
UMLS CUI 2011AA
C0740083
SNOMED CT 2011_0131
372103002
MedDRA 14.1
10018395
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
Description

T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection

Data type

boolean

Alias
UMLS CUI 2011AA
C0475373
SNOMED CT 2011_0131
67673008
UMLS CUI 2011AA
C0475374
SNOMED CT 2011_0131
14410001
UMLS CUI 2011AA
C0475751
SNOMED CT 2011_0131
65565005
UMLS CUI 2011AA
C1299240
SNOMED CT 2011_0131
372105009
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0023065
SNOMED CT 2011_0131
72791001
MedDRA 14.1
10023872
ICD-9-CM Version 2011
30
UMLS CUI 2011AA
C0226958
SNOMED CT 2011_0131
47975008
UMLS CUI 2011AA
CL421466
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
Description

T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection

Data type

boolean

Alias
UMLS CUI 2011AA
C0475373
SNOMED CT 2011_0131
67673008
UMLS CUI 2011AA
C0475374
SNOMED CT 2011_0131
14410001
UMLS CUI 2011AA
C0475751
SNOMED CT 2011_0131
65565005
UMLS CUI 2011AA
C0153398
SNOMED CT 2011_0131
448665005
MedDRA 14.1
10021042
ICD-10-CM Version 2010
C13
ICD-9-CM Version 2011
148.9
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0023065
SNOMED CT 2011_0131
72791001
MedDRA 14.1
10023872
ICD-9-CM Version 2011
30
UMLS CUI 2011AA
C0475373
SNOMED CT 2011_0131
67673008
UMLS CUI 2011AA
C0852722
MedDRA 14.1
10036334
UMLS CUI 2011AA
C0020629
SNOMED CT 2011_0131
81502006
UMLS CUI 2011AA
CL421466
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures
Description

N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0027530
SNOMED CT 2011_0131
45048000
LOINC Version 232
MTHU002688
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
MedDRA 14.1
10027449
UMLS CUI 2011AA
C0441959
SNOMED CT 2011_0131
62455006
UMLS CUI 2011AA
C0441962
SNOMED CT 2011_0131
53623008
UMLS CUI 2011AA
C0441960
SNOMED CT 2011_0131
46059003
UMLS CUI 2011AA
C0441961
SNOMED CT 2011_0131
5856006
UMLS CUI 2011AA
C0034991
SNOMED CT 2011_0131
52052004
MedDRA 14.1
10057374
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
Description

Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3

Data type

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0200633
SNOMED CT 2011_0131
30630007
MedDRA 14.1
10029363
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Clinical Chemistry Finding
Description

Clinical chemistry:

Data type

boolean

Alias
UMLS CUI 2011AA
C2347783
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
Description

adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0455273
SNOMED CT 2011_0131
273967009
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL
Description

adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
UMLS CUI 2011AA
C1519815
Electrolytes normal
Description

electrolytes at NL

Data type

boolean

Alias
UMLS CUI 2011AA
C0438240
SNOMED CT 2011_0131
166685005
anesthetic risk normal or low-grade elevated
Description

anesthetic risk normal or low-grade elevated

Data type

boolean

Alias
UMLS CUI 2011AA
C0002903
SNOMED CT 2011_0131
399248000
MedDRA 14.1
10067564
LOINC Version 232
MTHU035920
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0205307
SNOMED CT 2011_0131
17621005
HL7 V3 2006_05
N
UMLS CUI 2011AA
C0750482
SNOMED CT 2011_0131
425404009
UMLS CUI 2011AA
CL414623
age 18-75 years
Description

age 18-75 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)
Description

effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)

Data type

boolean

Alias
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C2911105
ICD-10-CM Version 2010
Z71.9
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0014939
SNOMED CT 2011_0131
41598000, 61946003
LOINC Version 232
MTHU003480
UMLS CUI 2011AA
C0033306
SNOMED CT 2011_0131
116614001, 20249007
UMLS CUI 2011AA
C0042260
UMLS CUI 2011AA
CL424926
UMLS CUI 2011AA
C0029968
UMLS CUI 2011AA
C0419518
SNOMED CT 2011_0131
312082008
MedDRA 14.1
10009849
UMLS CUI 2011AA
C0033308
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0033306
SNOMED CT 2011_0131
116614001, 20249007
UMLS CUI 2011AA
C0021902
UMLS CUI 2011AA
C0591309
SNOMED CT 2011_0131
50318003
LOINC Version 232
MTHU003615
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C1705186
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0024559
SNOMED CT 2011_0131
399141000
MedDRA 14.1
10065591
ICD-9-CM Version 2011
63.70
UMLS CUI 2011AA
C0042387
SNOMED CT 2011_0131
22523008
MedDRA 14.1
10047133
ICD-9-CM Version 2011
63.73
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
primary cancer treatable by operational larynx-conserving procedures
Description

primary cancer treatable by operational larynx-conserving procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C1306459
SNOMED CT 2011_0131
372087000
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0189204
SNOMED CT 2011_0131
387636004
MedDRA 14.1
10062034
UMLS CUI 2011AA
C0459914
SNOMED CT 2011_0131
281131004
distant metastases (M1-Status)
Description

distant metastases (M1-Status)

Data type

boolean

Alias
UMLS CUI 2011AA
CL278860
UMLS CUI 2011AA
C0441971
SNOMED CT 2011_0131
55440008
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
Description

total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)

Data type

boolean

Alias
UMLS CUI 2011AA
C0475276
SNOMED CT 2011_0131
258261001
UMLS CUI 2011AA
C0023078
SNOMED CT 2011_0131
4596009
LOINC Version 232
MTHU015048
UMLS CUI 2011AA
C0521324
UMLS CUI 2011AA
C0332448
SNOMED CT 2011_0131
47351003
UMLS CUI 2011AA
C0225317
SNOMED CT 2011_0131
87784001
LOINC Version 232
MTHU016974
UMLS CUI 2011AA
C1522619
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0007301
SNOMED CT 2011_0131
309312004
UMLS CUI 2011AA
C0332448
SNOMED CT 2011_0131
47351003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL425201
tumor-specific prior chemo- or radiotherapy
Description

tumor-specific prior chemo- or radiotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0034619
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
Description

metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]

Data type

boolean

Alias
UMLS CUI 2011AA
C1334703
UMLS CUI 2011AA
C0027663
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0475264
SNOMED CT 2011_0131
257880008
Life expectancy
Description

life expectancy < 3 month

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
Karnofsky performance status <70%
Description

Karnofsky performance status < 70%

Data type

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
Description

serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0034072
SNOMED CT 2011_0131
83291003, 274096000
MedDRA 14.1
10010971
ICD-10-CM Version 2010
I27.81
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C2348867
UMLS CUI 2011AA
C0035229
SNOMED CT 2011_0131
409623005
MedDRA 14.1
10038701
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
Description

Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)

Data type

boolean

Alias
UMLS CUI 2011AA
C0008679
SNOMED CT 2011_0131
27624003
UMLS CUI 2011AA
C0205355
SNOMED CT 2011_0131
6934004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
Description

recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician

Data type

boolean

Alias
UMLS CUI 2011AA
C0694550
MedDRA 14.1
10066727
UMLS CUI 2011AA
C0024117
SNOMED CT 2011_0131
13645005
MedDRA 14.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
UMLS CUI 2011AA
C1856359
UMLS CUI 2011AA
C0243087
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
CL415098
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
Description

Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
MedDRA 14.1
10010833
UMLS CUI 2011AA
C0699967
SNOMED CT 2011_0131
386918005
UMLS CUI 2011AA
C0008838
SNOMED CT 2011_0131
387318005
LOINC Version 232
MTHU016242
UMLS CUI 2011AA
C0016360
SNOMED CT 2011_0131
387172005
LOINC Version 232
MTHU016749
UMLS CUI 2011AA
C0995188
SNOMED CT 2011_0131
409400001
UMLS CUI 2011AA
C0034619
Expected absent patient compliance
Description

Expected absent patient compliance

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
Periodic follow-up not possible (for example address outside germany)
Description

Periodic follow-up not possible (for example address outside germany)

Data type

boolean

Alias
UMLS CUI 2011AA
C1522577
Pregnant or breast-feeding woman
Description

Pregnant or breast-feeding woman

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Absent or constricted legal capacity
Description

Absent or constricted legal capacity

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0443288
SNOMED CT 2011_0131
263856008
UMLS CUI 2011AA
C0683673
Participation to another clinical trial with any investigational study within 30 days prior to study screening
Description

Participation to another clinical trial with any investigational study within 30 days prior to study screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1409616
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
Item
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
CL414904 (UMLS CUI 2011AA)
C0023065 (UMLS CUI 2011AA)
72791001 (SNOMED CT 2011_0131)
10023872 (MedDRA 14.1)
30 (ICD-9-CM Version 2011)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023078 (UMLS CUI 2011AA)
4596009 (SNOMED CT 2011_0131)
MTHU015048 (LOINC Version 232)
C0020629 (UMLS CUI 2011AA)
81502006 (SNOMED CT 2011_0131)
T3-T4a carcinoma of the glottis
Item
T3-T4a carcinoma of the glottis
boolean
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C0740083 (UMLS CUI 2011AA)
372103002 (SNOMED CT 2011_0131)
10018395 (MedDRA 14.1)
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
Item
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
boolean
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C1299240 (UMLS CUI 2011AA)
372105009 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0023065 (UMLS CUI 2011AA)
72791001 (SNOMED CT 2011_0131)
10023872 (MedDRA 14.1)
30 (ICD-9-CM Version 2011)
C0226958 (UMLS CUI 2011AA)
47975008 (SNOMED CT 2011_0131)
CL421466 (UMLS CUI 2011AA)
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
Item
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
boolean
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C0153398 (UMLS CUI 2011AA)
448665005 (SNOMED CT 2011_0131)
10021042 (MedDRA 14.1)
C13 (ICD-10-CM Version 2010)
148.9 (ICD-9-CM Version 2011)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0023065 (UMLS CUI 2011AA)
72791001 (SNOMED CT 2011_0131)
10023872 (MedDRA 14.1)
30 (ICD-9-CM Version 2011)
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0852722 (UMLS CUI 2011AA)
10036334 (MedDRA 14.1)
C0020629 (UMLS CUI 2011AA)
81502006 (SNOMED CT 2011_0131)
CL421466 (UMLS CUI 2011AA)
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures
Item
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures
boolean
C0027530 (UMLS CUI 2011AA)
45048000 (SNOMED CT 2011_0131)
MTHU002688 (LOINC Version 232)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
C0441959 (UMLS CUI 2011AA)
62455006 (SNOMED CT 2011_0131)
C0441962 (UMLS CUI 2011AA)
53623008 (SNOMED CT 2011_0131)
C0441960 (UMLS CUI 2011AA)
46059003 (SNOMED CT 2011_0131)
C0441961 (UMLS CUI 2011AA)
5856006 (SNOMED CT 2011_0131)
C0034991 (UMLS CUI 2011AA)
52052004 (SNOMED CT 2011_0131)
10057374 (MedDRA 14.1)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
Item
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Clinical chemistry:
Item
Clinical Chemistry Finding
boolean
C2347783 (UMLS CUI 2011AA)
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
Item
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0455273 (UMLS CUI 2011AA)
273967009 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL
Item
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
electrolytes at NL
Item
Electrolytes normal
boolean
C0438240 (UMLS CUI 2011AA)
166685005 (SNOMED CT 2011_0131)
anesthetic risk normal or low-grade elevated
Item
anesthetic risk normal or low-grade elevated
boolean
C0002903 (UMLS CUI 2011AA)
399248000 (SNOMED CT 2011_0131)
10067564 (MedDRA 14.1)
MTHU035920 (LOINC Version 232)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0750482 (UMLS CUI 2011AA)
425404009 (SNOMED CT 2011_0131)
CL414623 (UMLS CUI 2011AA)
age 18-75 years
Item
age 18-75 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)
Item
effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male)
boolean
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C2911105 (UMLS CUI 2011AA)
Z71.9 (ICD-10-CM Version 2010)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0042260 (UMLS CUI 2011AA)
CL424926 (UMLS CUI 2011AA)
C0029968 (UMLS CUI 2011AA)
C0419518 (UMLS CUI 2011AA)
312082008 (SNOMED CT 2011_0131)
10009849 (MedDRA 14.1)
C0033308 (UMLS CUI 2011AA)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0021902 (UMLS CUI 2011AA)
C0591309 (UMLS CUI 2011AA)
50318003 (SNOMED CT 2011_0131)
MTHU003615 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C1705186 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0024559 (UMLS CUI 2011AA)
399141000 (SNOMED CT 2011_0131)
10065591 (MedDRA 14.1)
63.70 (ICD-9-CM Version 2011)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
primary cancer treatable by operational larynx-conserving procedures
Item
primary cancer treatable by operational larynx-conserving procedures
boolean
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0189204 (UMLS CUI 2011AA)
387636004 (SNOMED CT 2011_0131)
10062034 (MedDRA 14.1)
C0459914 (UMLS CUI 2011AA)
281131004 (SNOMED CT 2011_0131)
distant metastases (M1-Status)
Item
distant metastases (M1-Status)
boolean
CL278860 (UMLS CUI 2011AA)
C0441971 (UMLS CUI 2011AA)
55440008 (SNOMED CT 2011_0131)
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
Item
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria)
boolean
C0475276 (UMLS CUI 2011AA)
258261001 (SNOMED CT 2011_0131)
C0023078 (UMLS CUI 2011AA)
4596009 (SNOMED CT 2011_0131)
MTHU015048 (LOINC Version 232)
C0521324 (UMLS CUI 2011AA)
C0332448 (UMLS CUI 2011AA)
47351003 (SNOMED CT 2011_0131)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C1522619 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0007301 (UMLS CUI 2011AA)
309312004 (SNOMED CT 2011_0131)
C0332448 (UMLS CUI 2011AA)
47351003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
tumor-specific prior chemo- or radiotherapy
Item
tumor-specific prior chemo- or radiotherapy
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
Item
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator]
boolean
C1334703 (UMLS CUI 2011AA)
C0027663 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
CL425202 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0475264 (UMLS CUI 2011AA)
257880008 (SNOMED CT 2011_0131)
life expectancy < 3 month
Item
Life expectancy
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
Karnofsky performance status < 70%
Item
Karnofsky performance status <70%
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
Item
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0034072 (UMLS CUI 2011AA)
83291003, 274096000 (SNOMED CT 2011_0131)
10010971 (MedDRA 14.1)
I27.81 (ICD-10-CM Version 2010)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C2348867 (UMLS CUI 2011AA)
C0035229 (UMLS CUI 2011AA)
409623005 (SNOMED CT 2011_0131)
10038701 (MedDRA 14.1)
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
Item
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
boolean
C0008679 (UMLS CUI 2011AA)
27624003 (SNOMED CT 2011_0131)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
Item
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician
boolean
C0694550 (UMLS CUI 2011AA)
10066727 (MedDRA 14.1)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
C1856359 (UMLS CUI 2011AA)
C0243087 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
Item
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
boolean
C1301624 (UMLS CUI 2011AA)
10010833 (MedDRA 14.1)
C0699967 (UMLS CUI 2011AA)
386918005 (SNOMED CT 2011_0131)
C0008838 (UMLS CUI 2011AA)
387318005 (SNOMED CT 2011_0131)
MTHU016242 (LOINC Version 232)
C0016360 (UMLS CUI 2011AA)
387172005 (SNOMED CT 2011_0131)
MTHU016749 (LOINC Version 232)
C0995188 (UMLS CUI 2011AA)
409400001 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
Expected absent patient compliance
Item
Expected absent patient compliance
boolean
C1321605 (UMLS CUI 2011AA)
Periodic follow-up not possible (for example address outside germany)
Item
Periodic follow-up not possible (for example address outside germany)
boolean
C1522577 (UMLS CUI 2011AA)
Pregnant or breast-feeding woman
Item
Pregnant or breast-feeding woman
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Absent or constricted legal capacity
Item
Absent or constricted legal capacity
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0443288 (UMLS CUI 2011AA)
263856008 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
Participation to another clinical trial with any investigational study within 30 days prior to study screening
Item
Participation to another clinical trial with any investigational study within 30 days prior to study screening
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
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