Moderate dysplasia | Severe dysplasia | Squamous cell carcinoma in situ of oral cavity | Squamous cell carcinoma in situ of oropharynx
Item
patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
boolean
C0334047 (UMLS CUI [1])
C0334048 (UMLS CUI [2])
C4317014 (UMLS CUI [3])
C4317015 (UMLS CUI [4])
Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging
Item
patients with t1 squamous cell carcinoma of the oral cavity and/or oropharynx.
boolean
C0585362 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0280313 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Primary Lesion Treatment required for | Lesion Recurrent Treatment required for
Item
patient may have primary and/or recurrent lesions to be treated.
boolean
C1402294 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0332121 (UMLS CUI [2,3])
Diagnosis Confirmed by Biopsy
Item
diagnosis must confirmed by biopsy.
boolean
C0011900 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Prior Therapy allowed
Item
prior therapy of any type is allowed.
boolean
C1514463 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
Age | Gender Pregnancy Absent | Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Male sterilization
Item
male or female patients at least 18 years old. female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. male patients should be using a medically acceptable form of birth control or be sterile.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0024559 (UMLS CUI [7])
ECOG performance status
Item
patients must have an ecog score of 0-2 (appendix a 1 ).
boolean
C1520224 (UMLS CUI [1])
Comprehension Study Protocol | Comprehension Study Protocol Patient Representative | Informed Consent | Informed Consent Patient Representative
Item
patient or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Squamous cell carcinoma TNM clinical staging
Item
patients with t2 or greater squamous cell carcinoma.
boolean
C0007137 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lesion Base of tongue
Item
true tongue base lesions (as determined by the treating physician).
boolean
C0221198 (UMLS CUI [1,1])
C1284376 (UMLS CUI [1,2])
Trismus Severe | Access Lacking Lesion
Item
patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
boolean
C0041105 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
Porphyria | Hypersensitivity Porphyrin | Hypersensitivity Pharmaceutical Preparations Porphyrin Similar
Item
porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
boolean
C3463940 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0032712 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0032712 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
Liver Dysfunction | Alkaline phosphatase raised | Aspartate aminotransferase increased
Item
patients with impaired hepatic (alkaline phosphatase (hepatic) or sgot;:3 times the upper normal limits).
boolean
C0086565 (UMLS CUI [1])
C0151849 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency Minimal | Serum total bilirubin measurement | Creatinine measurement, serum
Item
patients with minimal impairment of renal function (total serum bilirubin;: 2 mg/dl, serum creatinine;: 2 mg/dl)
boolean
C1565489 (UMLS CUI [1,1])
C0547040 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
unwilling or unable to follow protocol requirements.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Condition Study Subject Participation Status Inappropriate | Patient Inappropriate Investigational New Drugs | Patient Inappropriate Investigational therapy
Item
any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug and or light treatment.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0949266 (UMLS CUI [3,3])
Chemotherapy | Therapeutic radiology procedure
Item
patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Inclusion criteria | Gender | Minorities
Item
inclusion of women and minorities:
boolean
C1512693 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0026192 (UMLS CUI [3])
Gender Both Eligible | Racial group All Eligible | Ethnic group All Eligible
Item
both men and women and members of all races and ethnic groups are eligible for this study.
boolean
C0079399 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0034510 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
C0015031 (UMLS CUI [3,1])
C0444868 (UMLS CUI [3,2])
C1548635 (UMLS CUI [3,3])