Age
Item
1. patients from 18 to 80 years of age (both inclusive)
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck | Squamous cell carcinoma of esophagus
Item
2. patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
boolean
C1168401 (UMLS CUI [1])
C0279626 (UMLS CUI [2])
Recurrent disease Local | Recurrent disease regional | Status of distant metastasis | Treatment Resistant Disorder | Disease Therapeutic procedure Amenable
Item
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
boolean
C0277556 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C1302548 (UMLS CUI [3])
C0871547 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C3900053 (UMLS CUI [5,3])
Tumor fragments Evaluable
Item
4. evaluable tumour deposits
boolean
C1298181 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
Life Expectancy
Item
5. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance score ≤ 2
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
7. patients must have given written informed consent (which must be consistent with international conference on harmonisation-good clinical practice (ich-gcp) and local legislation)
boolean
C0021430 (UMLS CUI [1])
Hypersensitivity Antibodies, Monoclonal, Humanized | Hypersensitivity Antibodies, Monoclonal, Murine-Derived | Hypersensitivity Immunoconjugates | Hypersensitivity Investigational New Drugs Excipient
Item
1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
boolean
C0020517 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2916903 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0243020 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Secondary Malignant Neoplasm Requirement Therapeutic procedure
Item
2. known secondary malignancy requiring therapy
boolean
C3266877 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Communicable Disease
Item
3. active infectious disease
boolean
C0009450 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Requirement Therapeutic procedure
Item
4. brain metastases requiring therapy
boolean
C0220650 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Neuropathy Grade
Item
5. neuropathy grade 2 or above
boolean
C0442874 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Absolute neutrophil count
Item
6. absolute neutrophil count less than 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
7. platelet count less than 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
8. bilirubin greater than 1.5 mg/dl (> 26 μmol/l, système internationale (si) unit equivalent)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
9. aspartate amino transferase (ast) and/or alanine amino transferase (alt) greater than 3 times the upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/l, si unit equivalent)
boolean
C0201976 (UMLS CUI [1])
Comorbidity Relevant Evaluation drug safety
Item
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
boolean
C0009488 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0678800 (UMLS CUI [1,4])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs
Item
12. chemo-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Gender Sexually active | Contraceptive methods Unwilling
Item
13. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
14. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Study Subject Participation Status
Item
15. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Study Protocol Compliance behavior Unable
Item
16. patients unable to comply with the protocol
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])