ID

37442

Description

A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell Carcinoma Larynx; ODM derived from: https://clinicaltrials.gov/show/NCT02207439

Link

https://clinicaltrials.gov/show/NCT02207439

Keywords

Versions (1)
  1. 7/26/19 7/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 26, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Stage III, IVa, or IVb Squamous Cell Carcinoma of the Larynx, With ECOG Performance Status 0-2 NCT02207439

English

Eligibility Stage III, IVa, or IVb Squamous Cell Carcinoma of the Larynx, With ECOG Performance Status 0-2 NCT02207439

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iii, iva, or ivb squamous cell carcinoma of the larynx, with ecog performance status 0-2
Description

Laryngeal Squamous Cell Carcinoma TNM clinical staging | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C0280324
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C1520224
patients 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
determined by the treating physician to be a candidate for organ preserving, concurrent standard chemotherapy and radiation therapy to the head and neck with definitive intent.
Description

Patient Appropriate Organ Preserving | Chemotherapy Head and neck | Radiotherapy to head and neck

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0728887
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0460004
UMLS CUI [3]
C3888854
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior radiation therapy to the head and neck prior chemotherapy within the past 5 years
Description

Prior radiation therapy Head and neck | Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0460004
UMLS CUI [2]
C1514457
previous therapy with a human immunodeficiency virus (hiv) protease inhibitor presence of t4b disease,precluding organ preservation pregnant or lactating patients. patients with known hiv disease.
Description

HIV Protease Inhibitor | Disease TNM clinical staging | Pregnancy | Breast Feeding | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C3536912
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
UMLS CUI [5]
C0019693
these patients have a high probability of treatment with anti-retroviral therapy which may interact with the nelfinavir.
Description

Antiretroviral therapy Interaction Nelfinavir

Data type

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0525005
absolute neutrophil count 1500 per mm3 platelet count 100,000 per mm3 serum creatinine 1.5 times the upper limit of normal serum ast or alt 2 times the upper limit of normal
Description

Absolute neutrophil count | Platelet Count measurement | Serum creatinine raised | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0700225
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
serum bilirubin 1.2 mg/dl weight loss of 10% over the past 6 months which is due to tumor wasting syndrome distant metastases patients receiving the following drugs that are contraindicated with nfv will be excluded.
Description

Serum bilirubin measurement | Weight loss Percentage Timespan | Etiology Malignant Neoplasm | Wasting Syndrome | Distant metastasis | Pharmaceutical Preparations Contraindicated Nelfinavir

Data type

boolean

Alias
UMLS CUI [1]
C0428441
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C0043046
UMLS CUI [5]
C1269798
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C1444657
UMLS CUI [6,3]
C0525005
Back to the top of the page

Similar models

Eligibility Stage III, IVa, or IVb Squamous Cell Carcinoma of the Larynx, With ECOG Performance Status 0-2 NCT02207439

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Laryngeal Squamous Cell Carcinoma TNM clinical staging | ECOG performance status
Item
stage iii, iva, or ivb squamous cell carcinoma of the larynx, with ecog performance status 0-2
boolean
C0280324 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1520224 (UMLS CUI [2])
Age
Item
patients 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Patient Appropriate Organ Preserving | Chemotherapy Head and neck | Radiotherapy to head and neck
Item
determined by the treating physician to be a candidate for organ preserving, concurrent standard chemotherapy and radiation therapy to the head and neck with definitive intent.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0728887 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2,1])
C0460004 (UMLS CUI [2,2])
C3888854 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Head and neck | Prior Chemotherapy
Item
prior radiation therapy to the head and neck prior chemotherapy within the past 5 years
boolean
C0279134 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
HIV Protease Inhibitor | Disease TNM clinical staging | Pregnancy | Breast Feeding | HIV Infection
Item
previous therapy with a human immunodeficiency virus (hiv) protease inhibitor presence of t4b disease,precluding organ preservation pregnant or lactating patients. patients with known hiv disease.
boolean
C3536912 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Antiretroviral therapy Interaction Nelfinavir
Item
these patients have a high probability of treatment with anti-retroviral therapy which may interact with the nelfinavir.
boolean
C1963724 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0525005 (UMLS CUI [1,3])
Absolute neutrophil count | Platelet Count measurement | Serum creatinine raised | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
absolute neutrophil count 1500 per mm3 platelet count 100,000 per mm3 serum creatinine 1.5 times the upper limit of normal serum ast or alt 2 times the upper limit of normal
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
Serum bilirubin measurement | Weight loss Percentage Timespan | Etiology Malignant Neoplasm | Wasting Syndrome | Distant metastasis | Pharmaceutical Preparations Contraindicated Nelfinavir
Item
serum bilirubin 1.2 mg/dl weight loss of 10% over the past 6 months which is due to tumor wasting syndrome distant metastases patients receiving the following drugs that are contraindicated with nfv will be excluded.
boolean
C0428441 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0043046 (UMLS CUI [4])
C1269798 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C1444657 (UMLS CUI [6,2])
C0525005 (UMLS CUI [6,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial