Tumor Mass de novo Larynx TNM clinical staging | Tumor Mass de novo Pharynx TNM clinical staging | Tumor Mass de novo Oral cavity TNM clinical staging
Item
patients must have a histologically confirmed and/or clinical and imaging evidence of a stage 1-4 de novo mass in the larynx, pharynx or oral cavity
boolean
C3273930 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0023078 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C3273930 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0031354 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C3273930 (UMLS CUI [3,1])
C1515568 (UMLS CUI [3,2])
C0226896 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
Treatment Plan Including Operative Surgical Procedures | Biopsy | Excision | Treatment Plan Including Therapeutic radiology procedure | Treatment Plan Including Chemotherapy
Item
treatment plan should include surgery (biopsy or excision) and may be followed by radiation and/ or concurrent chemotherapy
boolean
C0599880 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2])
C0728940 (UMLS CUI [3])
C0599880 (UMLS CUI [4,1])
C0332257 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C0599880 (UMLS CUI [5,1])
C0332257 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
Requirement Absent Emergency surgery
Item
patients' disease must not require emergency surgical attention
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4264510 (UMLS CUI [1,3])
Patient need for Tracheotomy | Patient need for FEEDING TUBE INSERTION
Item
the need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
boolean
C0686904 (UMLS CUI [1,1])
C0040591 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0743847 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
patients must have a karnofsky performance status >= 70
boolean
C0206065 (UMLS CUI [1])
Patient condition Standard therapy Surgical biopsy | Patient condition Standard therapy Excision
Item
patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection
boolean
C0683521 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0565118 (UMLS CUI [1,3])
C0683521 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
Organ function | Bone Marrow function
Item
patients must have normal organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
wbc > 2,000/mm^3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelets > 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier
Item
women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
Pregnancy | Pregnancy Suspected | Treating Physician Informed
Item
should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1710470 (UMLS CUI [3,1])
C1522154 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test
Item
serum pregnancy testing will be required for women of childbearing age
boolean
C3831118 (UMLS CUI [1,1])
C0430064 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
Allergic Reaction Flagyl | Allergic Reaction Metronidazole
Item
history of allergic reactions attributed to flagyl (metronidazole), which has a chemical structure similar to ef5
boolean
C1527304 (UMLS CUI [1,1])
C0699678 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0025872 (UMLS CUI [2,2])
Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant women and women who are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Clinical status Requirement Emergency surgery | SCCHN | F 18 EF5 PET scan Excluded
Item
patients whose clinical status requires that surgery for their hnscc be performed emergently or in a time course that does not allow scheduling of an 18f-ef5 pet scan preceding surgery and chemoradiation
boolean
C0449440 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4264510 (UMLS CUI [1,3])
C1168401 (UMLS CUI [2])
C1541539 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])