ID

39606

Beschreibung

Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN; ODM derived from: https://clinicaltrials.gov/show/NCT02124707

Link

https://clinicaltrials.gov/show/NCT02124707

Stichworte

Versionen (1)
  1. 02.02.20 02.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. Februar 2020

DOI

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Eligibility Head and Neck Cancer NCT02124707

Englisch

Eligibility Head and Neck Cancer NCT02124707

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (scchn). all primary sites are eligible excluding who type iii or ebv nasopharyngeal (who type i and who type ii allowed as long as they are ebv negative)
Beschreibung

Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Epstein-Barr Virus Negative

Datentyp

boolean

Alias
UMLS CUI [1]
C4524839
UMLS CUI [2]
C0744620
UMLS CUI [3,1]
C0014644
UMLS CUI [3,2]
C1513916
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and marrow function as defined below. laboratory tests should be completed within 14 days prior to registration: anc greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, hgb greather than 9g/dl (acceptable to reach this by transfusion), total bilirubin less than or equal to 1.5mg/dl, albumin greater than 2.5 g/dl, ast(sgot)/alt(sgpt) less than or equal to 2.5x institutional upper limit of normal, alkaline phosphatase less than or equal to 2.5 x upper limit of normal, gfr greater than 30 ml/min (by standard cockroft and gault formula or measured via 24 hour urine collection)
Beschreibung

Organ function | Bone Marrow function | Laboratory Procedures Completed | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Acceptable | Serum total bilirubin measurement | Albumin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Glomerular Filtration Rate Cockcroft-Gault formula | Glomerular Filtration Rate 24 Hour urine volume measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C0205197
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0518015
UMLS CUI [7,1]
C0005841
UMLS CUI [7,2]
C1879533
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201838
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201836
UMLS CUI [12]
C0201850
UMLS CUI [13,1]
C0017654
UMLS CUI [13,2]
C2924627
UMLS CUI [14,1]
C0017654
UMLS CUI [14,2]
C0427843
women of childbearing potential (wocbp) with negative serum or urine pregnancy test within 7 days of d1 of treatment
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
wocbp and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care.
Beschreibung

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraceptive methods Standard of Care | Contraceptive methods Combination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C2936643
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0205195
cancer must be considered incurable by the treating clinician
Beschreibung

Malignant Neoplasm incurable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0175969
ability to understand and willingness to sign a written informed consent document
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior cumulative exposure to > 300mg/m2 cisplatin, auc of 18 of carboplatin, or their combined equivalent within one year prior to enrollment
Beschreibung

Exposure to Cisplatin Dose | Exposure to Carboplatin AUC | Exposure to Equivalent Combined

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0008838
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0079083
UMLS CUI [2,3]
C0376690
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0205195
surgery or radiation within the four weeks prior to d1 of treatment under this protocol
Beschreibung

Operative Surgical Procedures | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
Beschreibung

Systemic Chemotherapy Previous | Exception Part of Curative treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1292711
UMLS CUI [2,3]
C1273390
other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion
Beschreibung

Cancer Other Invasive Treatment required for | Requirement Systemic therapy Expected | Exception Squamous cell carcinoma of skin Localized | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Requirement Local Ablation Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C1517001
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C0392752
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0547070
pregnant or lactating female
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Eligibility Head and Neck Cancer NCT02124707

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Epstein-Barr Virus Negative
Item
histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (scchn). all primary sites are eligible excluding who type iii or ebv nasopharyngeal (who type i and who type ii allowed as long as they are ebv negative)
boolean
C4524839 (UMLS CUI [1])
C0744620 (UMLS CUI [2])
C0014644 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | Laboratory Procedures Completed | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Transfusion Acceptable | Serum total bilirubin measurement | Albumin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Glomerular Filtration Rate Cockcroft-Gault formula | Glomerular Filtration Rate 24 Hour urine volume measurement
Item
adequate organ and marrow function as defined below. laboratory tests should be completed within 14 days prior to registration: anc greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, hgb greather than 9g/dl (acceptable to reach this by transfusion), total bilirubin less than or equal to 1.5mg/dl, albumin greater than 2.5 g/dl, ast(sgot)/alt(sgpt) less than or equal to 2.5x institutional upper limit of normal, alkaline phosphatase less than or equal to 2.5 x upper limit of normal, gfr greater than 30 ml/min (by standard cockroft and gault formula or measured via 24 hour urine collection)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0005841 (UMLS CUI [7,1])
C1879533 (UMLS CUI [7,2])
C1278039 (UMLS CUI [8])
C0201838 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201836 (UMLS CUI [11])
C0201850 (UMLS CUI [12])
C0017654 (UMLS CUI [13,1])
C2924627 (UMLS CUI [13,2])
C0017654 (UMLS CUI [14,1])
C0427843 (UMLS CUI [14,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
women of childbearing potential (wocbp) with negative serum or urine pregnancy test within 7 days of d1 of treatment
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraceptive methods Standard of Care | Contraceptive methods Combination
Item
wocbp and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
Malignant Neoplasm incurable
Item
cancer must be considered incurable by the treating clinician
boolean
C0006826 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exposure to Cisplatin Dose | Exposure to Carboplatin AUC | Exposure to Equivalent Combined
Item
history of prior cumulative exposure to > 300mg/m2 cisplatin, auc of 18 of carboplatin, or their combined equivalent within one year prior to enrollment
boolean
C0332157 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
C0376690 (UMLS CUI [2,3])
C0332157 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0205195 (UMLS CUI [3,3])
Operative Surgical Procedures | Therapeutic radiology procedure
Item
surgery or radiation within the four weeks prior to d1 of treatment under this protocol
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Systemic Chemotherapy Previous | Exception Part of Curative treatment
Item
prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
boolean
C1883256 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1292711 (UMLS CUI [2,2])
C1273390 (UMLS CUI [2,3])
Cancer Other Invasive Treatment required for | Requirement Systemic therapy Expected | Exception Squamous cell carcinoma of skin Localized | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Requirement Local Ablation Therapy
Item
other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0547070 (UMLS CUI [6,4])
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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