Squamous cell carcinoma of the head and neck | Exception Nasopharyngeal carcinoma Type | Excision of neoplasm Planned | Cutaneous Squamous Cell Carcinoma of the Head and Neck
Item
1. histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types ii and iii according to the world health organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
boolean
C1168401 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2931822 (UMLS CUI [2,2])
C0332307 (UMLS CUI [2,3])
C1299802 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C4524517 (UMLS CUI [4])
Availability of Tumor tissue sample Paraffin Embedded | Biomarker Evaluation | Antineoplastic Therapy Absent | Tumor tissue sample Unavailable | Tumor Biopsy
Item
2. there is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. no anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. if a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0085185 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C2346834 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0475358 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C0027651 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
Biological agents Targeted Therapy Epidermal Growth Factor Receptor
Item
3. prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
boolean
C0005515 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
Serum fasting glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus Diet therapy Stable | Diabetes Mellitus Therapy Stable
Item
4. the patient has a fasting serum glucose < 130 mg/dl and hba1c < 7.0%. patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
boolean
C0583334 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0012159 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0011849 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Renal function | Creatinine measurement, serum
Item
5. the patient has adequate renal function, defined by serum creatinine </= 1.5 * the institutional upper limit of normal (uln), or creatinine clearance >/=60 ml/min for patients with creatinine levels above the uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
6. because the teratogenicity of cetuximab and imc-a12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
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])
C0036899 (UMLS CUI [5])
Age
Item
7. the patient is age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
8. the patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
ECOG performance status
Item
9. eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Antineoplastic Agents
Item
1. patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
boolean
C0003392 (UMLS CUI [1])
Therapeutic radiology procedure
Item
2. patients receiving concomitant radiation.
boolean
C1522449 (UMLS CUI [1])
Targeted Therapy Insulin-Like-Growth Factor I Receptor
Item
3. prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
boolean
C2985566 (UMLS CUI [1,1])
C0140080 (UMLS CUI [1,2])
Allergic Reaction Compound Cetuximab Similar | Allergic Reaction Compound IMC-A12 Similar
Item
4. history of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or imc-a12.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0995188 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C3180625 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
5. pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Uncontrolled | Exacerbation Possible Due to Investigational New Drugs
Item
6. patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])