ID

37442

Beschreibung

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

Stichworte

Versionen (1)
  1. 26.07.19 26.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Stage III, IVa, or IVb Squamous Cell Carcinoma of the Larynx, With ECOG Performance Status 0-2 NCT02207439

Englisch

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

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Laryngeal Squamous Cell Carcinoma TNM clinical staging | ECOG performance status

Datentyp

boolean

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

Age

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Prior radiation therapy Head and neck | Prior Chemotherapy

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Antiretroviral therapy Interaction Nelfinavir

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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