ID

38585

Description

De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study; ODM derived from: https://clinicaltrials.gov/show/NCT02281955

Link

https://clinicaltrials.gov/show/NCT02281955

Keywords

Versions (1)
  1. 10/25/19 10/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT02281955

English

Eligibility Carcinoma, Squamous Cell NCT02281955

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ≥ 18 years of age (no upper age limit)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. t0-3, n0 to n2c, m0 squamous cell carcinoma of the oropharynx
Description

Squamous cell carcinoma of oropharynx TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0280313
UMLS CUI [1,2]
C3258246
3. biopsy proven squamous cell carcinoma that is hpv and/or p16 positive
Description

Squamous cell carcinoma HPV Positive | Squamous cell carcinoma p16 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C4288937
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C4289892
4. ≤ 10 pack-years smoking history or ≤ 30 pack-years smoking history with ≥ 5 years abstinence from smoking
Description

Smoking cigarettes: ____ pack-years history | Abstinence from smoking Duration

Data type

boolean

Alias
UMLS CUI [1]
C2230126
UMLS CUI [2,1]
C2042177
UMLS CUI [2,2]
C0449238
5. radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration
Description

Hematogenous metastases status Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0475457
UMLS CUI [1,2]
C1513916
6. ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
7. cbc/differential obtained within 8 weeks prior to registration, with adequate bone marrow function defined as follows: platelets ≥ 100,000 cells/mm3; hemoglobin ≥ 8.0 g/dl.
Description

CBC with differential | Bone Marrow function | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0545131
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
8. adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: serum creatinine < 2.0 mg/dl; total bilirubin < 2 x the institutional uln; ast or alt < 3 x the institutional uln.
Description

Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
9. negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
10. women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
Description

Childbearing Potential Sexually active Contraceptive methods | Gender Sexually active Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
11. patients must be deemed able to comply with the treatment plan and follow-up schedule.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
12. patients must provide study specific informed consent prior to study entry
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior history of radiation therapy to the head and neck
Description

Radiotherapy to head and neck

Data type

boolean

Alias
UMLS CUI [1]
C3888854
2. prior history of head and neck cancer.
Description

Malignant Head and Neck Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0278996
3. unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographgically involves the carotid arteries, nerves)
Description

Disease unresectable | Node Immobile Physical Examination | Disease nodal Involving Carotid Arteries | Disease nodal Involving Carotid nerve | Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0746922
UMLS CUI [2,2]
C0231441
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0443268
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0007272
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0443268
UMLS CUI [4,3]
C1314939
UMLS CUI [4,4]
C1282689
UMLS CUI [5]
C0034571
4. extensive history of using smokeless tobacco products or marijuana defined as daily use >/= 5 years.
Description

Smokeless Tobacco Use Extensive | Marijuana Smoking Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C4527315
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0024810
UMLS CUI [2,2]
C0205231
5. severe, active co-morbidity, defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (note, however, coagulation parameters are not required for entry into this protocol); pre-existing ≥ grade 2 neuropathy; prior organ transplant.
Description

Comorbidity Severe | Angina, Unstable | Congestive heart failure Hospitalization Required | Transmural myocardial infarction | Bacterial Infection | Mycoses | Requirement Antibiotics Intravenous | COPD exacerbation | Respiration Disorder Hospitalization Required | Respiration Disorder Excludes Investigational Therapy | Hepatic Insufficiency Resulting in Icterus | Hepatic Insufficiency Resulting in Coagulation Defects | Neuropathy Pre-existing CTCAE Grades | Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1708385
UMLS CUI [4]
C1400513
UMLS CUI [5]
C0004623
UMLS CUI [6]
C0026946
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C0003232
UMLS CUI [7,3]
C1522726
UMLS CUI [8]
C0740304
UMLS CUI [9,1]
C0035204
UMLS CUI [9,2]
C1708385
UMLS CUI [10,1]
C0035204
UMLS CUI [10,2]
C0332196
UMLS CUI [10,3]
C0949266
UMLS CUI [11,1]
C1306571
UMLS CUI [11,2]
C0332294
UMLS CUI [11,3]
C0022346
UMLS CUI [12,1]
C1306571
UMLS CUI [12,2]
C0332294
UMLS CUI [12,3]
C0005779
UMLS CUI [13,1]
C0442874
UMLS CUI [13,2]
C2347662
UMLS CUI [13,3]
C1516728
UMLS CUI [14]
C0029216
6. known hiv positive.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Carcinoma, Squamous Cell NCT02281955

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. ≥ 18 years of age (no upper age limit)
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of oropharynx TNM clinical staging
Item
2. t0-3, n0 to n2c, m0 squamous cell carcinoma of the oropharynx
boolean
C0280313 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Squamous cell carcinoma HPV Positive | Squamous cell carcinoma p16 Positive
Item
3. biopsy proven squamous cell carcinoma that is hpv and/or p16 positive
boolean
C0007137 (UMLS CUI [1,1])
C4288937 (UMLS CUI [1,2])
C0007137 (UMLS CUI [2,1])
C4289892 (UMLS CUI [2,2])
Smoking cigarettes: ____ pack-years history | Abstinence from smoking Duration
Item
4. ≤ 10 pack-years smoking history or ≤ 30 pack-years smoking history with ≥ 5 years abstinence from smoking
boolean
C2230126 (UMLS CUI [1])
C2042177 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Hematogenous metastases status Negative
Item
5. radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration
boolean
C0475457 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
ECOG performance status
Item
6. ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
CBC with differential | Bone Marrow function | Platelet Count measurement | Hemoglobin measurement
Item
7. cbc/differential obtained within 8 weeks prior to registration, with adequate bone marrow function defined as follows: platelets ≥ 100,000 cells/mm3; hemoglobin ≥ 8.0 g/dl.
boolean
C0545131 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
8. adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: serum creatinine < 2.0 mg/dl; total bilirubin < 2 x the institutional uln; ast or alt < 3 x the institutional uln.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Childbearing Potential Serum pregnancy test negative
Item
9. negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Childbearing Potential Sexually active Contraceptive methods | Gender Sexually active Contraceptive methods
Item
10. women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Protocol Compliance
Item
11. patients must be deemed able to comply with the treatment plan and follow-up schedule.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
12. patients must provide study specific informed consent prior to study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to head and neck
Item
1. prior history of radiation therapy to the head and neck
boolean
C3888854 (UMLS CUI [1])
Malignant Head and Neck Neoplasm
Item
2. prior history of head and neck cancer.
boolean
C0278996 (UMLS CUI [1])
Disease unresectable | Node Immobile Physical Examination | Disease nodal Involving Carotid Arteries | Disease nodal Involving Carotid nerve | Radiography
Item
3. unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographgically involves the carotid arteries, nerves)
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0746922 (UMLS CUI [2,1])
C0231441 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0443268 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0007272 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0443268 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
C1282689 (UMLS CUI [4,4])
C0034571 (UMLS CUI [5])
Smokeless Tobacco Use Extensive | Marijuana Smoking Extensive
Item
4. extensive history of using smokeless tobacco products or marijuana defined as daily use >/= 5 years.
boolean
C4527315 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0024810 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
Comorbidity Severe | Angina, Unstable | Congestive heart failure Hospitalization Required | Transmural myocardial infarction | Bacterial Infection | Mycoses | Requirement Antibiotics Intravenous | COPD exacerbation | Respiration Disorder Hospitalization Required | Respiration Disorder Excludes Investigational Therapy | Hepatic Insufficiency Resulting in Icterus | Hepatic Insufficiency Resulting in Coagulation Defects | Neuropathy Pre-existing CTCAE Grades | Organ Transplantation
Item
5. severe, active co-morbidity, defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (note, however, coagulation parameters are not required for entry into this protocol); pre-existing ≥ grade 2 neuropathy; prior organ transplant.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1708385 (UMLS CUI [3,2])
C1400513 (UMLS CUI [4])
C0004623 (UMLS CUI [5])
C0026946 (UMLS CUI [6])
C1514873 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
C1522726 (UMLS CUI [7,3])
C0740304 (UMLS CUI [8])
C0035204 (UMLS CUI [9,1])
C1708385 (UMLS CUI [9,2])
C0035204 (UMLS CUI [10,1])
C0332196 (UMLS CUI [10,2])
C0949266 (UMLS CUI [10,3])
C1306571 (UMLS CUI [11,1])
C0332294 (UMLS CUI [11,2])
C0022346 (UMLS CUI [11,3])
C1306571 (UMLS CUI [12,1])
C0332294 (UMLS CUI [12,2])
C0005779 (UMLS CUI [12,3])
C0442874 (UMLS CUI [13,1])
C2347662 (UMLS CUI [13,2])
C1516728 (UMLS CUI [13,3])
C0029216 (UMLS CUI [14])
HIV Seropositivity
Item
6. known hiv positive.
boolean
C0019699 (UMLS CUI [1])
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