ID

39342

Description

IAEA-HypoX. Accelerated Radiotherapy With or Without Nimorazole in Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT01507467

Link

https://clinicaltrials.gov/show/NCT01507467

Keywords

Versions (1)
  1. 12/23/19 12/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Carcinoma NCT01507467

English

Eligibility Head and Neck Carcinoma NCT01507467

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
tumor classified as stage i-iv located in oropharynx, hypopharynx, larynx (not glottic stage i-ii), or oral cavity according to the tnm classification.
Description

Malignant neoplasm of oropharynx TNM clinical staging | Hypopharyngeal Cancer TNM clinical staging | Malignant neoplasm of larynx TNM clinical staging | Absent Malignant neoplasm of glottis TNM clinical staging | Malignant neoplasm of mouth TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0153382
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0153398
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0007107
UMLS CUI [3,2]
C3258246
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0153483
UMLS CUI [4,3]
C3258246
UMLS CUI [5,1]
C0153381
UMLS CUI [5,2]
C3258246
histopathological diagnosis of invasive squamous cell carcinoma in the primary tumor.
Description

Squamous cell carcinoma Invasive Primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0677930
informed consent according to the helsinki declaration and local regula-tions.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
Description

Patients Appropriate Teleradiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0419095
performance status 0-2 according to who criteria.
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
the patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
Description

Absence Symptoms Peripheral Neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0031117
normal function of liver and kidney by routine laboratory examinations. the patient must not be pregnant
Description

Liver function | Renal function | Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
distant metastases.
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
the patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
Description

Condition Influence Treatment outcome | Condition Complicating Assessment | Condition Complicating Follow-up | Condition Reduced life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0085415
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1522701
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1522701
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1858274
surgical excision (except biopsy), prior or planned (including elective neck dissection).
Description

Excision | Exception Biopsy | Excision Planned | Neck Dissection elective

Data type

boolean

Alias
UMLS CUI [1]
C0728940
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0398395
UMLS CUI [4,2]
C0439608
the existence of synchronous multiple malignancies (not leukoplakia).
Description

Multiple malignancy Synchronous | Exception Leukoplakia

Data type

boolean

Alias
UMLS CUI [1,1]
C0346429
UMLS CUI [1,2]
C0439580
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023531
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Similar models

Eligibility Head and Neck Carcinoma NCT01507467

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of oropharynx TNM clinical staging | Hypopharyngeal Cancer TNM clinical staging | Malignant neoplasm of larynx TNM clinical staging | Absent Malignant neoplasm of glottis TNM clinical staging | Malignant neoplasm of mouth TNM clinical staging
Item
tumor classified as stage i-iv located in oropharynx, hypopharynx, larynx (not glottic stage i-ii), or oral cavity according to the tnm classification.
boolean
C0153382 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0153398 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0007107 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0153483 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C0153381 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
Squamous cell carcinoma Invasive Primary tumor
Item
histopathological diagnosis of invasive squamous cell carcinoma in the primary tumor.
boolean
C0007137 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
Informed Consent
Item
informed consent according to the helsinki declaration and local regula-tions.
boolean
C0021430 (UMLS CUI [1])
Patients Appropriate Teleradiotherapy
Item
the patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0419095 (UMLS CUI [1,3])
WHO performance status scale
Item
performance status 0-2 according to who criteria.
boolean
C1298650 (UMLS CUI [1])
Absence Symptoms Peripheral Neuropathy
Item
the patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0031117 (UMLS CUI [1,3])
Liver function | Renal function | Pregnancy Absent
Item
normal function of liver and kidney by routine laboratory examinations. the patient must not be pregnant
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
distant metastases.
boolean
C1269798 (UMLS CUI [1])
Condition Influence Treatment outcome | Condition Complicating Assessment | Condition Complicating Follow-up | Condition Reduced life expectancy
Item
the patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
boolean
C0348080 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0085415 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1522701 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1522701 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1858274 (UMLS CUI [4,2])
Excision | Exception Biopsy | Excision Planned | Neck Dissection elective
Item
surgical excision (except biopsy), prior or planned (including elective neck dissection).
boolean
C0728940 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0728940 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0398395 (UMLS CUI [4,1])
C0439608 (UMLS CUI [4,2])
Multiple malignancy Synchronous | Exception Leukoplakia
Item
the existence of synchronous multiple malignancies (not leukoplakia).
boolean
C0346429 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023531 (UMLS CUI [2,2])
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