Age
Item
1. age ≥21 years
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck Invasive Untreated Disease length | Recurrent Head and Neck Squamous Cell Carcinoma Untreated Disease length | Treatment completed Primary disorder | Recurrence Last | Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of mouth Advanced TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of oropharynx Advanced TNM clinical staging | Laryngeal Squamous Cell Carcinoma TNM clinical staging | Laryngeal Squamous Cell Carcinoma Advanced TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx Advanced TNM clinical staging | Squamous cell carcinoma of unknown primary TNM clinical staging | Squamous cell carcinoma of unknown primary Advanced TNM clinical staging | Neoplasm Metastasis Absent | Therapeutic radiology procedure | Chemotherapy | Chemotherapy Absent
Item
2. histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma or histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence). patients may have local stage i or ii, or locoregionally advanced hnscc stage iii or iv of the oral cavity, oropharynx, larynx, hypopharynx, or unknown primary, but no metastatic disease; intent to treat with primary radiotherapy +/-chemotherapy
boolean
C1168401 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0872146 (UMLS CUI [1,4])
C4524839 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0872146 (UMLS CUI [2,3])
C0580352 (UMLS CUI [3,1])
C0277554 (UMLS CUI [3,2])
C2825055 (UMLS CUI [4,1])
C1517741 (UMLS CUI [4,2])
C0585362 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
C0585362 (UMLS CUI [6,1])
C0205179 (UMLS CUI [6,2])
C3258246 (UMLS CUI [6,3])
C0280313 (UMLS CUI [7,1])
C3258246 (UMLS CUI [7,2])
C0280313 (UMLS CUI [8,1])
C0205179 (UMLS CUI [8,2])
C3258246 (UMLS CUI [8,3])
C0280324 (UMLS CUI [9,1])
C3258246 (UMLS CUI [9,2])
C0280324 (UMLS CUI [10,1])
C0205179 (UMLS CUI [10,2])
C3258246 (UMLS CUI [10,3])
C0280321 (UMLS CUI [11,1])
C3258246 (UMLS CUI [11,2])
C0280321 (UMLS CUI [12,1])
C0205179 (UMLS CUI [12,2])
C3258246 (UMLS CUI [12,3])
C0280097 (UMLS CUI [13,1])
C3258246 (UMLS CUI [13,2])
C0280097 (UMLS CUI [14,1])
C0205179 (UMLS CUI [14,2])
C3258246 (UMLS CUI [14,3])
C0027627 (UMLS CUI [15,1])
C0332197 (UMLS CUI [15,2])
C1522449 (UMLS CUI [16])
C0392920 (UMLS CUI [17])
C0392920 (UMLS CUI [18,1])
C0332197 (UMLS CUI [18,2])
Disease Amenable Biopsy | Outpatient | Biopsy Routine Clinic
Item
3. disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
boolean
C0012634 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0029921 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C1547137 (UMLS CUI [3,2])
C0442592 (UMLS CUI [3,3])
ECOG performance status
Item
4. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Obtain laboratory data Required
Item
5. required laboratory data (to be obtained within 2 weeks of initiation):
boolean
C0677148 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelets > 75,000/mm³
boolean
C0032181 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance (crcl)> 60 ml/min
boolean
C2711451 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total serum bilirubin < 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Informed Consent
Item
6. willingness and ability to give signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Medical contraindication Biopsy Target Lesion
Item
1. medical contraindication to biopsy of target lesion
boolean
C1301624 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
Comorbidity Preventing Treatment Protocol | Comorbidity Preventing Conventional Treatment
Item
2. intercurrent illness likely to prevent protocol therapy or conventional planned therapy
boolean
C0009488 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2945704 (UMLS CUI [2,3])
tadalafil | Phosphodiesterase 5 inhibitor Active Long-term
Item
3. prior daily use of tadalafil or other long-acting pde5 inhibitors for one month or greater
boolean
C1176316 (UMLS CUI [1])
C1318700 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
Severe allergy Tadalafil | Severe allergy Tadalafil Excipient
Item
4. known severe hypersensitivity to tadalafil or any of the excipients of this product
boolean
C2945656 (UMLS CUI [1,1])
C1176316 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C1176316 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Nitrates
Item
5. current treatment with nitrates
boolean
C0028125 (UMLS CUI [1])
Systemic therapy | CYP3A4 Inhibitor Strong | Ketoconazole | Ritonavir
Item
6. current systemic treatment with a potent cytochrome p450 3a4 (cyp3a4) inhibitor such as ketoconazole or ritonavir
boolean
C1515119 (UMLS CUI [1])
C3830624 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0022625 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
Hypotension | Blindness | Relationship Prior Therapy | tadalafil | Phosphodiesterase 5 inhibitor
Item
7. history of hypotension and/or blindness during prior treatment with tadalafil or other pde-5 inhibitors
boolean
C0020649 (UMLS CUI [1])
C0456909 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1176316 (UMLS CUI [4])
C1318700 (UMLS CUI [5])
Retinal Disease Ischemic | Involvement Arterial Absent
Item
8. prior history of non-arterial ischemic optic retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0221464 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Diphtheria vaccines allergy
Item
9. prior adverse reaction to diphtheria vaccine
boolean
C0571552 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative
Item
10. pregnant or breastfeeding; a negative pregnancy test is required within 14 days of randomization for all women of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Curative treatment Cancer Other | Curative treatment Malignant Neoplasm Previous | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Cervix carcinoma | Life Expectancy
Item
11. concurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer), for which the survival prognosis is < 5 years
boolean
C1273390 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
C0023671 (UMLS CUI [6])
Drugs, Non-Prescription | Investigational New Drugs
Item
12. treatment with a non-approved or investigational drug within 30 days before visit 1
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Healing Incomplete Surgery Oncologic | Healing Incomplete Major surgery
Item
13. incomplete healing from previous oncologic or other major surgery
boolean
C0043240 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0205478 (UMLS CUI [1,4])
C0043240 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C0679637 (UMLS CUI [2,3])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated
Item
14. as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0018799 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205433 (UMLS CUI [10,2])
Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
15. evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Hypotensive episode Hospitalization Required
Item
16. history of significant hypotensive episode requiring hospitalization
boolean
C0520541 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Myocardial Infarction | Angina Pectoris Uncontrolled | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled
Item
17. history of acute myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Heart condition
Item
18. history of any of the following cardiac conditions:
boolean
C3842523 (UMLS CUI [1])
Angina Pectoris | Requirement Nitrates Active Long-term | Requirement Nitrates Active short-term | Angina, Unstable | Cardiac stress test normal | Interventional procedure cardiac absent
Item
i. angina requiring treatment with long-acting nitrates ii. angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration iii. unstable angina within 90 days of visit 1 (braunwald 1989) iv. positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
boolean
C0002962 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C0205177 (UMLS CUI [2,3])
C0443252 (UMLS CUI [2,4])
C1514873 (UMLS CUI [3,1])
C0028125 (UMLS CUI [3,2])
C0205177 (UMLS CUI [3,3])
C0443303 (UMLS CUI [3,4])
C0002965 (UMLS CUI [4])
C1096370 (UMLS CUI [5])
C0184661 (UMLS CUI [6,1])
C0018787 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Condition Coronary
Item
19. history of any of the following coronary conditions within 90 days of planned tadalafil administration:
boolean
C0348080 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angioplasty | Placement of stent | Heart Disease New York Heart Association Classification
Item
i. myocardial infarction ii. coronary artery bypass graft surgery iii. percutaneous coronary intervention (for example, angioplasty or stent placement) iv. any evidence of heart disease (nyha≥class iii as defined in protocol attachment lvhg.3) within 6 months of planned tadalafil administration
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0162577 (UMLS CUI [4])
C0522776 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
Immunosuppression chronic | AIDS | Therapeutic immunosuppression
Item
20. prior chronic immune suppressive state (aids, immunosuppressive therapy)
boolean
C4048329 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001175 (UMLS CUI [2])
C0021079 (UMLS CUI [3])