Squamous cell carcinoma of the head and neck Initially | Recurrent Head and Neck Squamous Cell Carcinoma | Squamous cell carcinoma of mouth | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Squamous cell carcinoma of the oral cavity recurrent | Oropharyngeal squamous cell carcinoma recurrent | Squamous cell carcinoma of the hypopharynx recurrent | Laryngeal squamous cell carcinoma recurrent
Item
histologically confirmed diagnosis initially or at relapse of scchn of the oral cavity, oropharynx, hypopharynx or larynx
boolean
C1168401 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C4524839 (UMLS CUI [2])
C0585362 (UMLS CUI [3])
C0280313 (UMLS CUI [4])
C0280321 (UMLS CUI [5])
C0280324 (UMLS CUI [6])
C0861556 (UMLS CUI [7])
C0280376 (UMLS CUI [8])
C0280392 (UMLS CUI [9])
C0280401 (UMLS CUI [10])
Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Surgery | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Surgery | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Therapeutic radiology procedure Curative | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Therapeutic radiology procedure Curative | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Chemoradiotherapy Curative | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Chemoradiotherapy Curative
Item
recurrent and/or metastatic scchn not amenable to curative treatment with surgery and/or (chemo)radiation
boolean
C4524839 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
C0744620 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1511562 (UMLS CUI [2,3])
C4524839 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
C0744620 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
C4524839 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0436307 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C0744620 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C0436307 (UMLS CUI [6,3])
C1276305 (UMLS CUI [6,4])
Anti-egfr monoclonal antibody therapy Palliative | Combined Modality Therapy | Chemotherapy | Therapeutic radiology procedure
Item
previous treatment with an anti-egfr monoclonal antibody (mab) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
boolean
C4316122 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C0009429 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Benefit Clinical Anti-egfr monoclonal antibody therapy | Response Anti-egfr monoclonal antibody therapy | Partial response | In complete remission | Stable Disease
Item
documented clinical benefit or response for at least 8 weeks (pr, cr or sd) on the anti-egfr mab-based therapy and
boolean
C0814225 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C4316122 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C4316122 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C0677946 (UMLS CUI [5])
Disease Progression CT scan | Disease Progression MRI | Status post Anti-egfr monoclonal antibody therapy
Item
documented disease progression (verified by computed tomography [ct] scan or magnetic resonance imaging [mri] according to recist (1.1) during or within 12 weeks following the last administration of anti-egfr mab
boolean
C0242656 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C4316122 (UMLS CUI [3,2])
Neoplasm Amenable Biopsy | Neoplasm Biopsy Repeated
Item
accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
boolean
C0027651 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Inclusion criteria Study Protocol
Item
other protocol-defined inclusion criteria could apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Prior Chemotherapy Palliative Quantity
Item
more than 2 lines of prior chemotherapy in the palliative setting
boolean
C1514457 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Life Expectancy
Item
expected survival <12 weeks
boolean
C0023671 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
subjects with known brain metastases
boolean
C0220650 (UMLS CUI [1])
Chemotherapy Recent | Therapeutic radiology procedure Recent | Exception Therapeutic radiology procedure Palliative Hemorrhage | Exception Therapeutic radiology procedure Palliative Pain
Item
chemotherapy or radiation therapy within 21 days prior to visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1285530 (UMLS CUI [3,3])
C0019080 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C1285530 (UMLS CUI [4,3])
C0030193 (UMLS CUI [4,4])
Anti-egfr monoclonal antibody therapy Recent
Item
anti-egfr mabs within 14 days prior to visit 2
boolean
C4316122 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Major surgery | Toxicity Due to Major surgery | Patient recovered
Item
major surgery within 4 weeks prior to visit 2 and subjects must have recovered from effects of major surgery
boolean
C0679637 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0679637 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])