ID

23182

Beskrivning

Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) Versus Intensity Modulated Radiotherapy (IMRT) for Head and Neck Squamous Cell Carcinoma (HNSCC); ODM derived from: https://clinicaltrials.gov/show/NCT00652613

Länk

https://clinicaltrials.gov/show/NCT00652613

Nyckelord

  1. 2017-06-26 2017-06-26 -
Uppladdad den

26 juni 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00652613

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00652613

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy proven squamous cell carcinoma of the oropharynx or laryngopharynx.
Beskrivning

Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx

Datatyp

boolean

Alias
UMLS CUI [1]
C0280313
UMLS CUI [2]
C0280321
ajcc stage t1-3, no-2b, mo patients with pre-treatment tumor measurements clinically as well as on ct/mri scans.
Beskrivning

TNM clinical staging | Tumor Size Measurement pre treatment clinical | Tumor Size Measurement pre treatment CT scan | Tumor Size Measurement pre treatment MRI Scan

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C3827751
UMLS CUI [2,2]
C2709094
UMLS CUI [2,3]
C0205210
UMLS CUI [3,1]
C3827751
UMLS CUI [3,2]
C2709094
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C3827751
UMLS CUI [4,2]
C2709094
UMLS CUI [4,3]
C0917711
surgery of the primary tumor limited to excisional or incisional biopsy.
Beskrivning

Operative Surgical Procedures Primary tumor | Excision biopsy Primary tumor | Incisional biopsy Primary tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0184921
UMLS CUI [2,2]
C0677930
UMLS CUI [3,1]
C0184922
UMLS CUI [3,2]
C0677930
no form of neck dissection for nodal metastases.
Beskrivning

Secondary malignant neoplasm of lymph node | Neck Dissection Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0686619
UMLS CUI [2,1]
C0398395
UMLS CUI [2,2]
C0332197
kps > 60 (see appendix i).
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
age > 18 and < 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
no prior history of therapeutic irradiation.
Beskrivning

Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
patient willing and reliable for follow-up.
Beskrivning

Clinical Study Follow-up Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0600109
patient's nutritional & physical condition compatible with planned therapy.
Beskrivning

Condition Nutritional Consistent with Therapeutic procedure Planned | Physical Condition Consistent with Therapeutic procedure Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1521739
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C1301732
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1301732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of distant metastases.
Beskrivning

Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C1302548
previous therapeutic irradiation for head & neck cancer or any other invasive cancer other than squamous or basal cell carcinoma of the skin.
Beskrivning

Therapeutic radiology procedure Cancer of Head and Neck | Therapeutic radiology procedure Invasive cancer | Squamous cell carcinoma of skin Excluded | Basal cell carcinoma Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0278996
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0677898
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C2828389
UMLS CUI [4,1]
C0007117
UMLS CUI [4,2]
C2828389
history of prior malignancy.
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
prophylactic use of amifostine or pilocarpine.
Beskrivning

Amifostine Prophylactic | Pilocarpine Prophylactic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015020
UMLS CUI [1,2]
C0199176
UMLS CUI [2,1]
C0031923
UMLS CUI [2,2]
C0199176
active untreated infection like tuberculosis, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
Beskrivning

Communicable Disease untreated Excludes Systemic Chemotherapy | Communicable Disease untreated Interferes with Treatment completion | Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C1883256
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0580352
UMLS CUI [3]
C0041296
any histopathology other than squamous carcinoma.
Beskrivning

Histopathology finding | Squamous cell carcinoma Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0428093
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C2828389
primary nasopharyngeal carcinoma.
Beskrivning

Nasopharyngeal carcinoma Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0205225
age < 18 or > 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy or lactating women.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00652613

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx
Item
biopsy proven squamous cell carcinoma of the oropharynx or laryngopharynx.
boolean
C0280313 (UMLS CUI [1])
C0280321 (UMLS CUI [2])
TNM clinical staging | Tumor Size Measurement pre treatment clinical | Tumor Size Measurement pre treatment CT scan | Tumor Size Measurement pre treatment MRI Scan
Item
ajcc stage t1-3, no-2b, mo patients with pre-treatment tumor measurements clinically as well as on ct/mri scans.
boolean
C3258246 (UMLS CUI [1])
C3827751 (UMLS CUI [2,1])
C2709094 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C3827751 (UMLS CUI [3,1])
C2709094 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C3827751 (UMLS CUI [4,1])
C2709094 (UMLS CUI [4,2])
C0917711 (UMLS CUI [4,3])
Operative Surgical Procedures Primary tumor | Excision biopsy Primary tumor | Incisional biopsy Primary tumor
Item
surgery of the primary tumor limited to excisional or incisional biopsy.
boolean
C0543467 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0184921 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0184922 (UMLS CUI [3,1])
C0677930 (UMLS CUI [3,2])
Secondary malignant neoplasm of lymph node | Neck Dissection Absent
Item
no form of neck dissection for nodal metastases.
boolean
C0686619 (UMLS CUI [1])
C0398395 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
kps > 60 (see appendix i).
boolean
C0206065 (UMLS CUI [1])
Age
Item
age > 18 and < 65 years.
boolean
C0001779 (UMLS CUI [1])
Therapeutic radiology procedure Absent
Item
no prior history of therapeutic irradiation.
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Clinical Study Follow-up Willing
Item
patient willing and reliable for follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Condition Nutritional Consistent with Therapeutic procedure Planned | Physical Condition Consistent with Therapeutic procedure Planned
Item
patient's nutritional & physical condition compatible with planned therapy.
boolean
C0348080 (UMLS CUI [1,1])
C1521739 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1301732 (UMLS CUI [1,5])
C3714565 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
evidence of distant metastases.
boolean
C1302548 (UMLS CUI [1])
Therapeutic radiology procedure Cancer of Head and Neck | Therapeutic radiology procedure Invasive cancer | Squamous cell carcinoma of skin Excluded | Basal cell carcinoma Excluded
Item
previous therapeutic irradiation for head & neck cancer or any other invasive cancer other than squamous or basal cell carcinoma of the skin.
boolean
C1522449 (UMLS CUI [1,1])
C0278996 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0677898 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0007117 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Malignant Neoplasms
Item
history of prior malignancy.
boolean
C0006826 (UMLS CUI [1])
Amifostine Prophylactic | Pilocarpine Prophylactic
Item
prophylactic use of amifostine or pilocarpine.
boolean
C0015020 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0031923 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Communicable Disease untreated Excludes Systemic Chemotherapy | Communicable Disease untreated Interferes with Treatment completion | Tuberculosis
Item
active untreated infection like tuberculosis, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
boolean
C0009450 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1883256 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
C0041296 (UMLS CUI [3])
Histopathology finding | Squamous cell carcinoma Excluded
Item
any histopathology other than squamous carcinoma.
boolean
C0428093 (UMLS CUI [1])
C0007137 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Nasopharyngeal carcinoma Primary
Item
primary nasopharyngeal carcinoma.
boolean
C2931822 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Age
Item
age < 18 or > 65 years.
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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