ID

37006

Description

De-intensification of Radiation and Chemotherapy for Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01530997 The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.

Link

https://clinicaltrials.gov/show/NCT01530997

Keywords

Versions (2)
  1. 2019-06-29 2019-06-29 -
  2. 2021-09-17 2021-09-17 -
Copyright Holder

UNC Lineberger Comprehensive Cancer Center

Uploaded on

29 juni 2019

DOI

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License

Creative Commons BY-NC 3.0
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Radiation in Low-Risk HPV Squamous Cell Carcinoma NCT01530997

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant above 18 years of age?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have t0-3, n0 to n2c, m0 squamous cell carcinoma of the oropharynx?
Description

Oropharyngeal squamous cell carcinoma stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0280313
UMLS CUI [1,2]
C1515169
UMLS CUI [2]
C3833426
UMLS CUI [3]
C0475371
UMLS CUI [4]
C0475373
UMLS CUI [5]
C0475374
UMLS CUI [6]
C0445034
Does the participant have. biopsy proven squamous cell carcinoma that is HPV and/or p16 positive?
Description

HPV/p16 positive squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0280313
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C4288937
UMLS CUI [2,1]
C0280313
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C4289892
Does the participant have ≤ 10 pack-years smoking history or > 5 years of abstinence from smoking?
Description

Smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C4721824
UMLS CUI [1,2]
C1277691
UMLS CUI [2]
C0814442
Did the participant have history/physical examination within 8 weeks prior to registration?
Description

History/physical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2985881
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C2985881
Does the participant have radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration?
Description

No metastasis seen

Data type

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1512376
UMLS CUI [1,4]
C0027627
UMLS CUI [1,5]
C0332152
UMLS CUI [1,6]
C2985881
Does the participant have an ecog performance status 0-1?
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Does the participant have a CBC/Differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: absolute neutrophil count (anc) ≥ 1,800 cells/mm3; platelets ≥ 100,000 cells/mm3; hemoglobin ≥ 8.0 g/dl?
Description

Adequate bone marrow function

Data type

boolean

Alias
UMLS CUI [1,1]
C0009555
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0005953
UMLS CUI [1,4]
C0542341
UMLS CUI [2,1]
C0545131
UMLS CUI [2,2]
C0205411
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C0542341
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
Does the participant have 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

Adequate Renal and Hepatic function

Data type

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0232741
UMLS CUI [2,1]
C0205411
UMLS CUI [2,2]
C0232804
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201913
UMLS CUI [5]
C0004002
UMLS CUI [6]
C0001899
Does the participant have a negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential?
Description

Negative serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1,1]
C0430061
UMLS CUI [1,2]
C3831118
Does the participant practice adequate contraception during treatment and for 6 weeks following treatment, if they are a women of childbearing potential or male participants who are sexually active?
Description

Adequate contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C4324275
UMLS CUI [2,1]
C0205411
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332282
UMLS CUI [2,4]
C0087111
UMLS CUI [2,5]
C0241028
UMLS CUI [2,6]
C0025266
Is the participant deemed able to comply with the treatment plan and follow-up schedule?
Description

Able to comply

Data type

boolean

Alias
UMLS CUI [1]
C0582784
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0725694
UMLS CUI [2,3]
C1522577
Does the participant 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
Does the participant have a prior history of radiation therapy to the head and neck?
Description

History of head/neck radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0018670
UMLS CUI [1,3]
C0027530
Does the participant have a prior history of head and neck cancer?
Description

Head/Neck cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278996
Does the participant have a 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

Severe active comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0009488
UMLS CUI [1,4]
C1704788
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C0019993
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0019993
UMLS CUI [4]
C1400513
UMLS CUI [5,1]
C0004623
UMLS CUI [5,2]
C0013125
UMLS CUI [5,3]
C0003232
UMLS CUI [6,1]
C0026946
UMLS CUI [6,2]
C0013125
UMLS CUI [6,3]
C0003235
UMLS CUI [7,1]
C0740304
UMLS CUI [7,2]
C0019993
UMLS CUI [8]
C1306571
UMLS CUI [9]
C0442874
UMLS CUI [10]
C0524930
Is the participant known HIV positive?
Description

HIV positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
Does the participant have significant pre-existing hearing loss, as defined by the patient or treating physician?
Description

Significant hearing loss

Data type

boolean

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C3887873
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0011900
UMLS CUI [2,1]
C2347662
UMLS CUI [2,2]
C3887873
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C0031831
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant above 18 years of age?
boolean
C0001779 (UMLS CUI [1])
Oropharyngeal squamous cell carcinoma stage
Item
Does the participant have t0-3, n0 to n2c, m0 squamous cell carcinoma of the oropharynx?
boolean
C0280313 (UMLS CUI [1,1])
C1515169 (UMLS CUI [1,2])
C3833426 (UMLS CUI [2])
C0475371 (UMLS CUI [3])
C0475373 (UMLS CUI [4])
C0475374 (UMLS CUI [5])
C0445034 (UMLS CUI [6])
HPV/p16 positive squamous cell carcinoma
Item
Does the participant have. biopsy proven squamous cell carcinoma that is HPV and/or p16 positive?
boolean
C0280313 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C4288937 (UMLS CUI [1,3])
C0280313 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C4289892 (UMLS CUI [2,3])
Smoking history
Item
Does the participant have ≤ 10 pack-years smoking history or > 5 years of abstinence from smoking?
boolean
C4721824 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C0814442 (UMLS CUI [2])
History/physical examination
Item
Did the participant have history/physical examination within 8 weeks prior to registration?
boolean
C0262926 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2985881 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C2985881 (UMLS CUI [2,3])
No metastasis seen
Item
Does the participant have radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration?
boolean
C0043299 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1512376 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,5])
C2985881 (UMLS CUI [1,6])
ECOG
Item
Does the participant have an ecog performance status 0-1?
boolean
C1520224 (UMLS CUI [1])
Adequate bone marrow function
Item
Does the participant have a CBC/Differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: absolute neutrophil count (anc) ≥ 1,800 cells/mm3; platelets ≥ 100,000 cells/mm3; hemoglobin ≥ 8.0 g/dl?
boolean
C0009555 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C0542341 (UMLS CUI [1,4])
C0545131 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0542341 (UMLS CUI [2,4])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Adequate Renal and Hepatic function
Item
Does the participant have 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
C0205411 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0205411 (UMLS CUI [2,1])
C0232804 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0004002 (UMLS CUI [5])
C0001899 (UMLS CUI [6])
Negative serum pregnancy test
Item
Does the participant have a negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential?
boolean
C0430061 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Adequate contraception
Item
Does the participant practice adequate contraception during treatment and for 6 weeks following treatment, if they are a women of childbearing potential or male participants who are sexually active?
boolean
C0205411 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C4324275 (UMLS CUI [1,5])
C0205411 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0241028 (UMLS CUI [2,5])
C0025266 (UMLS CUI [2,6])
Able to comply
Item
Is the participant deemed able to comply with the treatment plan and follow-up schedule?
boolean
C0582784 (UMLS CUI [1])
C0085732 (UMLS CUI [2,1])
C0725694 (UMLS CUI [2,2])
C1522577 (UMLS CUI [2,3])
Informed Consent
Item
Does the participant provide study specific informed consent prior to study entry?
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
History of head/neck radiation
Item
Does the participant have a prior history of radiation therapy to the head and neck?
boolean
C1522449 (UMLS CUI [1,1])
C0018670 (UMLS CUI [1,2])
C0027530 (UMLS CUI [1,3])
Head/Neck cancer
Item
Does the participant have a prior history of head and neck cancer?
boolean
C0278996 (UMLS CUI [1])
Severe active comorbidity
Item
Does the participant have a 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
C0205082 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C1704788 (UMLS CUI [1,4])
C0002965 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C0019993 (UMLS CUI [3,2])
C1400513 (UMLS CUI [4])
C0004623 (UMLS CUI [5,1])
C0013125 (UMLS CUI [5,2])
C0003232 (UMLS CUI [5,3])
C0026946 (UMLS CUI [6,1])
C0013125 (UMLS CUI [6,2])
C0003235 (UMLS CUI [6,3])
C0740304 (UMLS CUI [7,1])
C0019993 (UMLS CUI [7,2])
C1306571 (UMLS CUI [8])
C0442874 (UMLS CUI [9])
C0524930 (UMLS CUI [10])
HIV positive
Item
Is the participant known HIV positive?
boolean
C0019699 (UMLS CUI [1])
Significant hearing loss
Item
Does the participant have significant pre-existing hearing loss, as defined by the patient or treating physician?
boolean
C2347662 (UMLS CUI [1,1])
C3887873 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
C2347662 (UMLS CUI [2,1])
C3887873 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0031831 (UMLS CUI [2,4])
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