ID

23182

Description

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

Link

https://clinicaltrials.gov/show/NCT00652613

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00652613

English

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00652613

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Secondary malignant neoplasm of lymph node | Neck Dissection Absent

Data type

boolean

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

Karnofsky Performance Status

Data type

boolean

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

Age

Data type

boolean

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

Therapeutic radiology procedure Absent

Data type

boolean

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

Clinical Study Follow-up Willing

Data type

boolean

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

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of distant metastases.
Description

Distant metastasis

Data type

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.
Description

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

Data type

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.
Description

Malignant Neoplasms

Data type

boolean

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

Amifostine Prophylactic | Pilocarpine Prophylactic

Data type

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.
Description

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

Data type

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.
Description

Histopathology finding | Squamous cell carcinoma Excluded

Data type

boolean

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

Nasopharyngeal carcinoma Primary

Data type

boolean

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

Age

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT00652613

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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