ID

39131

Beschreibung

A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR); ODM derived from: https://clinicaltrials.gov/show/NCT01590355

Link

https://clinicaltrials.gov/show/NCT01590355

Stichworte

Versionen (1)
  1. 03.12.19 03.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Dezember 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Early-Stage Squamous Cell Carcinoma of the Oropharynx NCT01590355

Englisch

Eligibility Early-Stage Squamous Cell Carcinoma of the Oropharynx NCT01590355

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
willing to provide informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
Beschreibung

Squamous cell carcinoma of oropharynx | Including Tonsil | Including Soft Palate | Including Base of tongue | Including Wall of oropharynx

Datentyp

boolean

Alias
UMLS CUI [1]
C0280313
UMLS CUI [2,1]
C0332257
UMLS CUI [2,2]
C0836921
UMLS CUI [3,1]
C0332257
UMLS CUI [3,2]
C0030219
UMLS CUI [4,1]
C0332257
UMLS CUI [4,2]
C0226958
UMLS CUI [5,1]
C0332257
UMLS CUI [5,2]
C0926831
tumour stage:t1 or t2, with likely negative resections at surgery
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
nodal stage: n0, n1 (<=3cm), or n2 (up to 2 nodes between 1-3cm, on either side of the neck), without extranodal extension on pre-randomization imaging.
Beschreibung

TNM clinical staging | Cervical lymph nodes Quantity | Size of lymph node

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0588054
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C1285847
patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization.
Beschreibung

Patient Assessed Head and neck Clinic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0460004
UMLS CUI [1,4]
C0442592
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
Beschreibung

Comorbidity Serious | Medical contraindication Therapeutic radiology procedure | Medical contraindication Chemotherapy | Medical contraindication Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0392920
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0543467
prior history of head and neck cancer within 5 years
Beschreibung

Malignant Head and Neck Neoplasm Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278996
UMLS CUI [1,2]
C0205156
prior head and neck radiation at any time
Beschreibung

Radiation therapy to the head and neck

Datentyp

boolean

Alias
UMLS CUI [1]
C4540910
metastatic disease
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
inability to attend full course of radiotherapy or follow-up visits
Beschreibung

Radiotherapy Course Attend Unable | Follow-up visit Attend Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1999232
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1999232
UMLS CUI [2,3]
C1299582
neck disease with unknown primary site
Beschreibung

Disorder of neck Primary Site Unknown

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0558385
UMLS CUI [1,2]
C1709668
prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
Beschreibung

Malignant disease Invasive | Exception Disease Free Duration | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442867
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
unable or unwilling to complete qol questionnaires
Beschreibung

Quality of life Questionnaire Complete Unable | Quality of life Questionnaire Complete Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0034380
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0558080
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Ähnliche Modelle

Eligibility Early-Stage Squamous Cell Carcinoma of the Oropharynx NCT01590355

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Squamous cell carcinoma of oropharynx | Including Tonsil | Including Soft Palate | Including Base of tongue | Including Wall of oropharynx
Item
histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
boolean
C0280313 (UMLS CUI [1])
C0332257 (UMLS CUI [2,1])
C0836921 (UMLS CUI [2,2])
C0332257 (UMLS CUI [3,1])
C0030219 (UMLS CUI [3,2])
C0332257 (UMLS CUI [4,1])
C0226958 (UMLS CUI [4,2])
C0332257 (UMLS CUI [5,1])
C0926831 (UMLS CUI [5,2])
TNM clinical staging
Item
tumour stage:t1 or t2, with likely negative resections at surgery
boolean
C3258246 (UMLS CUI [1])
TNM clinical staging | Cervical lymph nodes Quantity | Size of lymph node
Item
nodal stage: n0, n1 (<=3cm), or n2 (up to 2 nodes between 1-3cm, on either side of the neck), without extranodal extension on pre-randomization imaging.
boolean
C3258246 (UMLS CUI [1])
C0588054 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1285847 (UMLS CUI [3])
Patient Assessed Head and neck Clinic
Item
patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization.
boolean
C0030705 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0460004 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Comorbidity Serious | Medical contraindication Therapeutic radiology procedure | Medical contraindication Chemotherapy | Medical contraindication Operative Surgical Procedures
Item
serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
Malignant Head and Neck Neoplasm Previous
Item
prior history of head and neck cancer within 5 years
boolean
C0278996 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Radiation therapy to the head and neck
Item
prior head and neck radiation at any time
boolean
C4540910 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Radiotherapy Course Attend Unable | Follow-up visit Attend Unable
Item
inability to attend full course of radiotherapy or follow-up visits
boolean
C1522449 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1999232 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0589121 (UMLS CUI [2,1])
C1999232 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Disorder of neck Primary Site Unknown
Item
neck disease with unknown primary site
boolean
C0558385 (UMLS CUI [1,1])
C1709668 (UMLS CUI [1,2])
Malignant disease Invasive | Exception Disease Free Duration | Exception Skin carcinoma
Item
prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
boolean
C0442867 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Quality of life Questionnaire Complete Unable | Quality of life Questionnaire Complete Unwilling
Item
unable or unwilling to complete qol questionnaires
boolean
C0034380 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0034380 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
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