ID

44499

Beschreibung

Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00671437

Link

https://clinicaltrials.gov/show/NCT00671437

Stichworte

Versionen (2)
  1. 18.11.17 18.11.17 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT00671437

Englisch

Eligibility Carcinoma, Squamous Cell NCT00671437

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven diagnosis of squamous cell carcinoma of the head and neck (scchn).
Beschreibung

Squamous cell carcinoma of the head and neck

Datentyp

boolean

Alias
UMLS CUI [1]
C1168401
have either locally recurrent, unresectable, previously irradiated scchn or metastatic scchn, with at least one measurable tumor lesion (by ct scan) and at least one fdg avid (suv >/= 3, >/= 1.5 cm) tumor lesion (by pet/ct).
Beschreibung

HEAD NECK CANCER SQUAMOUS CELL RECURRENT Local | Squamous cell carcinoma of the head and neck unresectable | Therapeutic radiology procedure Squamous cell carcinoma of the head and neck | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Neoplasm Measurable lesion Quantity CT scan | Neoplasm Lesion FDG SUV PET/CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4524839
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1168401
UMLS CUI [4]
C0744620
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C1513041
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C0040405
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C0221198
UMLS CUI [6,3]
C0046056
UMLS CUI [6,4]
C2348529
UMLS CUI [6,5]
C1699633
age greater than 18 yrs.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-3
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
signed irb approved informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical history of severe interstitial lung disease (not copd)-as defined by prior pft's with residual volume, total lung capacity, or corrected dlco <30% of predicted. for this study, screening pft's required only if clinically indicated.
Beschreibung

Interstitial Lung Disease Severe | Exception COPD | Residual volume Pulmonary function tests | Total Lung Capacity | DLCO Corrected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024117
UMLS CUI [3,1]
C0035190
UMLS CUI [3,2]
C0024119
UMLS CUI [4]
C0040509
UMLS CUI [5,1]
C1516251
UMLS CUI [5,2]
C0205202
prior therapy with an egfr-specific monoclonal antibody (mab) for treatment of metastatic scchn. prior therapy with an egfr-specific mab as part of the definitive treatment of non-metastatic scchn is acceptable if this occurred more than three months previously. prior therapy with an egfr specific tki will not be an exclusion factor.
Beschreibung

Monoclonal Antibodies EGFR Specific HEAD NECK CANCER SQUAMOUS CELL METASTATIC

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0034802
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C0744620
women of child bearing potential who are current pregnant or breast feeding.
Beschreibung

Childbearing Potential Pregnancy | Childbearing Potential Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0006147
prior severe (grade 4) infusion reaction to cetuximab.
Beschreibung

Infusion reaction Severe Cetuximab | Infusion reaction CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368034
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0995188
UMLS CUI [2,1]
C2368034
UMLS CUI [2,2]
C1516728
a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
Beschreibung

Disease Serious Uncontrolled | Protocol Compliance Impaired

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0221099
chemotherapy, radiation therapy, or investigational agents given with the last 14 days.
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0013230
uncontrolled diabetes mellitus. (subjects with a fasting blood glucose > 200 at time of pet scanning may need to reschedule to another day after consulting with appropriate physicians.)
Beschreibung

Diabetic - poor control | Fasting blood glucose measurement | Positron-Emission Tomography

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0032743
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Ähnliche Modelle

Eligibility Carcinoma, Squamous Cell NCT00671437

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck
Item
histologically proven diagnosis of squamous cell carcinoma of the head and neck (scchn).
boolean
C1168401 (UMLS CUI [1])
HEAD NECK CANCER SQUAMOUS CELL RECURRENT Local | Squamous cell carcinoma of the head and neck unresectable | Therapeutic radiology procedure Squamous cell carcinoma of the head and neck | HEAD NECK CANCER SQUAMOUS CELL METASTATIC | Neoplasm Measurable lesion Quantity CT scan | Neoplasm Lesion FDG SUV PET/CT
Item
have either locally recurrent, unresectable, previously irradiated scchn or metastatic scchn, with at least one measurable tumor lesion (by ct scan) and at least one fdg avid (suv >/= 3, >/= 1.5 cm) tumor lesion (by pet/ct).
boolean
C4524839 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1168401 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C1168401 (UMLS CUI [3,2])
C0744620 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C1513041 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0040405 (UMLS CUI [5,4])
C0027651 (UMLS CUI [6,1])
C0221198 (UMLS CUI [6,2])
C0046056 (UMLS CUI [6,3])
C2348529 (UMLS CUI [6,4])
C1699633 (UMLS CUI [6,5])
Age
Item
age greater than 18 yrs.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-3
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed irb approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Interstitial Lung Disease Severe | Exception COPD | Residual volume Pulmonary function tests | Total Lung Capacity | DLCO Corrected
Item
clinical history of severe interstitial lung disease (not copd)-as defined by prior pft's with residual volume, total lung capacity, or corrected dlco <30% of predicted. for this study, screening pft's required only if clinically indicated.
boolean
C0206062 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0024117 (UMLS CUI [2,2])
C0035190 (UMLS CUI [3,1])
C0024119 (UMLS CUI [3,2])
C0040509 (UMLS CUI [4])
C1516251 (UMLS CUI [5,1])
C0205202 (UMLS CUI [5,2])
Monoclonal Antibodies EGFR Specific HEAD NECK CANCER SQUAMOUS CELL METASTATIC
Item
prior therapy with an egfr-specific monoclonal antibody (mab) for treatment of metastatic scchn. prior therapy with an egfr-specific mab as part of the definitive treatment of non-metastatic scchn is acceptable if this occurred more than three months previously. prior therapy with an egfr specific tki will not be an exclusion factor.
boolean
C0003250 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0744620 (UMLS CUI [1,4])
Childbearing Potential Pregnancy | Childbearing Potential Breast Feeding
Item
women of child bearing potential who are current pregnant or breast feeding.
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
Infusion reaction Severe Cetuximab | Infusion reaction CTCAE Grades
Item
prior severe (grade 4) infusion reaction to cetuximab.
boolean
C2368034 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0995188 (UMLS CUI [1,3])
C2368034 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Disease Serious Uncontrolled | Protocol Compliance Impaired
Item
a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
chemotherapy, radiation therapy, or investigational agents given with the last 14 days.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Diabetic - poor control | Fasting blood glucose measurement | Positron-Emission Tomography
Item
uncontrolled diabetes mellitus. (subjects with a fasting blood glucose > 200 at time of pet scanning may need to reschedule to another day after consulting with appropriate physicians.)
boolean
C0421258 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
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