ID

39897

Description

Weekly Cetuximab/RT Versus Weekly Cisplatin/RT in HPV-Associated Oropharyngeal Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01855451

Lien

https://clinicaltrials.gov/show/NCT01855451

Mots-clés

Versions (1)
  1. 02/03/2020 02/03/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

2 mars 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility HPV Positive Oropharyngeal Squamous Cell Carcinoma NCT01855451

Anglais

Eligibility HPV Positive Oropharyngeal Squamous Cell Carcinoma NCT01855451

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged 18 years or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. has provided written informed consent for participation in this trial
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
3. histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive status confirmed locally by immunohistochemistry
Description

Squamous cell carcinoma of oropharynx | p16 Positive Immunohistochemistry

Type de données

boolean

Alias
UMLS CUI [1]
C0280313
UMLS CUI [2,1]
C4289892
UMLS CUI [2,2]
C0021044
4. stage iii (excluding t1-2n1) or stage iv (excluding t4, n3, and distant metastasis) if smoking history of < /=10 pack years. if > 10 pack years nodal disease must be n0- n2a.
Description

TNM clinical staging | Smoking cigarettes: ____ pack-years history

Type de données

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C2230126
5. if an excisional biopsy has been performed, patients remain eligible for the study provided there is clinically measurable disease prior to commencing rt. the residual disease should still meet the stage criteria required for the trial e.g. excisional biopsy of a node with residual t3 primary, or tonsillectomy for t1 primary with residual > n2a nodes.
Description

Excision biopsy | Measurable Disease | Status pre- Therapeutic radiology procedure | Residual Tumor | Tonsillectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0184921
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C1522449
UMLS CUI [4]
C0543478
UMLS CUI [5]
C0040423
6. no prior treatment for oropharyngeal cancer
Description

Prior Therapy Absent Oropharyngeal Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2349952
7. adequate haematological, renal, and hepatic function as defined by,
Description

Hematologic function | Renal function | Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
1. absolute neutrophil count (anc, segs + bands) > /= 1.5 x 109/l
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count > /= 100 x 109/l
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
3. total bilirubin < /= 1.5 x upper normal limit
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
4. alt < /= 2.5 x upper normal limit
Description

Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201836
5. calculated creatinine clearance (cockcroft-gault formula) or isotopic gfr > 55ml/min
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Glomerular Filtration Rate Isotopic

Type de données

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2,1]
C0017654
UMLS CUI [2,2]
C4038403
8. ecog performance status score of 0-1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
9. participants capable of childbearing are using adequate contraception and intend to continue use of contraception for at least 6 months following completion of treatment
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
10. negative pregnancy test within 72 hours prior to randomisation of women who are of childbearing potential
Description

Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
11. suitable for follow-up for at least 24 months as per trial protocol.
Description

Patient Appropriate Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C3274571
12. sufficient proficiency in english, cognitive capacity and willingness to complete questionnaires
Description

Proficiency English Language | Questionnaires Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678997
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of unknown primary of the head and neck
Description

Unknown primary neoplasia site Head and neck

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221297
UMLS CUI [1,2]
C0460004
2. t4, n3 or distant metastases
Description

TNM clinical staging | Distant metastasis

Type de données

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C1269798
3. smoking history >10 pack years with n2b or c nodal status
Description

Smoking cigarettes: ____ pack-years history | TNM clinical staging Lymph nodal status

Type de données

boolean

Alias
UMLS CUI [1]
C2230126
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C0449927
4. women who are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. previous radiotherapy to the area to be treated (excluding superficial radiotherapy for a cutaneous malignancy)
Description

Prior radiation therapy Area Involved | Exception Superficial radiation treatment Skin carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0841519
UMLS CUI [2,3]
C0699893
6. previous cisplatin or carboplatin chemotherapy
Description

Cisplatin Prior Chemotherapy | Carboplatin Prior Chemotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008838
UMLS CUI [1,2]
C1514457
UMLS CUI [2,1]
C0079083
UMLS CUI [2,2]
C1514457
7. prior egfr targeted therapy of any kind
Description

EGFR Targeted Therapy Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0205156
8. primary surgery to the affected area (excisional biopsy allowed)
Description

Operative Surgical Procedure Area affected | Exception Biopsy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
9. peripheral neuropathy > /= grade 2 (ctcae v4.0)
Description

Peripheral Neuropathy CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
10. sensori-neural hearing impairment >= grade 2 (ctcae v4.0, hearing impaired, not enrolled on a monitoring program) which may be exacerbated by cisplatin (audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion)
Description

Sensorineural Hearing Impairment CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018784
UMLS CUI [1,2]
C1516728
11. tinnitus > /= grade 2 (ctcae v4.0)
Description

Tinnitus CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040264
UMLS CUI [1,2]
C1516728
12. history of interstitial lung disease or evidence of interstitial lung disease on pre-registration ct
Description

Lung Disease, Interstitial | Interstitial Lung Disease CT

Type de données

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2,1]
C0206062
UMLS CUI [2,2]
C0040405
13. history of myocardial infarction within 12 months prior to study entry, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled psychotic disorders, active serious infections, active peptic ulcer disease, immunosuppression due to post-organ transplantation or use of immunosuppressants for autoimmune disorders
Description

Myocardial Infarction | Congestive heart failure Uncontrolled | Angina, Unstable | Cardiomyopathy | Cardiac Arrhythmia Unstable | Psychotic Disorders Uncontrolled | Communicable Diseases Serious | Peptic Ulcer | Immunosuppression Post Organ Transplantation | Immunosuppressive Agents Autoimmune Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0878544
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0033975
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0205404
UMLS CUI [8]
C0030920
UMLS CUI [9,1]
C4048329
UMLS CUI [9,2]
C0687676
UMLS CUI [9,3]
C0029216
UMLS CUI [10,1]
C0021081
UMLS CUI [10,2]
C0004364
14. patients known to be hiv positive
Description

HIV Seropositivity

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
15. other cancer that was diagnosed:
Description

Cancer Other

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
1. more than 5 years prior to current diagnosis with (i) subsequent evidence of disease recurrence or (ii) clinical expectation of recurrence is greater than 10% or
Description

Disease recurrence | Disease recurrence Expected

Type de données

boolean

Alias
UMLS CUI [1]
C0679254
UMLS CUI [2,1]
C0679254
UMLS CUI [2,2]
C1517001
2. within 5 years of the current diagnosis, with the exception of successfully treated basal cell or squamous cell skin carcinoma, in situ melanoma, or carcinoma in situ of the cervix
Description

Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Malignant melanoma in situ Treated | Exception Carcinoma in situ of uterine cervix Treated

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007117
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0854696
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
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Similar models

Eligibility HPV Positive Oropharyngeal Squamous Cell Carcinoma NCT01855451

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. has provided written informed consent for participation in this trial
boolean
C0021430 (UMLS CUI [1])
Squamous cell carcinoma of oropharynx | p16 Positive Immunohistochemistry
Item
3. histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive status confirmed locally by immunohistochemistry
boolean
C0280313 (UMLS CUI [1])
C4289892 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
TNM clinical staging | Smoking cigarettes: ____ pack-years history
Item
4. stage iii (excluding t1-2n1) or stage iv (excluding t4, n3, and distant metastasis) if smoking history of < /=10 pack years. if > 10 pack years nodal disease must be n0- n2a.
boolean
C3258246 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Excision biopsy | Measurable Disease | Status pre- Therapeutic radiology procedure | Residual Tumor | Tonsillectomy
Item
5. if an excisional biopsy has been performed, patients remain eligible for the study provided there is clinically measurable disease prior to commencing rt. the residual disease should still meet the stage criteria required for the trial e.g. excisional biopsy of a node with residual t3 primary, or tonsillectomy for t1 primary with residual > n2a nodes.
boolean
C0184921 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0332152 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0543478 (UMLS CUI [4])
C0040423 (UMLS CUI [5])
Prior Therapy Absent Oropharyngeal Carcinoma
Item
6. no prior treatment for oropharyngeal cancer
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2349952 (UMLS CUI [1,3])
Hematologic function | Renal function | Liver function
Item
7. adequate haematological, renal, and hepatic function as defined by,
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc, segs + bands) > /= 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count > /= 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
3. total bilirubin < /= 1.5 x upper normal limit
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
4. alt < /= 2.5 x upper normal limit
boolean
C0201836 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Glomerular Filtration Rate Isotopic
Item
5. calculated creatinine clearance (cockcroft-gault formula) or isotopic gfr > 55ml/min
boolean
C2711451 (UMLS CUI [1])
C0017654 (UMLS CUI [2,1])
C4038403 (UMLS CUI [2,2])
ECOG performance status
Item
8. ecog performance status score of 0-1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
9. participants capable of childbearing are using adequate contraception and intend to continue use of contraception for at least 6 months following completion of treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative
Item
10. negative pregnancy test within 72 hours prior to randomisation of women who are of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Patient Appropriate Follow-up
Item
11. suitable for follow-up for at least 24 months as per trial protocol.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Proficiency English Language | Questionnaires Completion
Item
12. sufficient proficiency in english, cognitive capacity and willingness to complete questionnaires
boolean
C0678997 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Unknown primary neoplasia site Head and neck
Item
1. history of unknown primary of the head and neck
boolean
C0221297 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
TNM clinical staging | Distant metastasis
Item
2. t4, n3 or distant metastases
boolean
C3258246 (UMLS CUI [1])
C1269798 (UMLS CUI [2])
Smoking cigarettes: ____ pack-years history | TNM clinical staging Lymph nodal status
Item
3. smoking history >10 pack years with n2b or c nodal status
boolean
C2230126 (UMLS CUI [1])
C3258246 (UMLS CUI [2,1])
C0449927 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
4. women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior radiation therapy Area Involved | Exception Superficial radiation treatment Skin carcinoma
Item
5. previous radiotherapy to the area to be treated (excluding superficial radiotherapy for a cutaneous malignancy)
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0841519 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
Cisplatin Prior Chemotherapy | Carboplatin Prior Chemotherapy
Item
6. previous cisplatin or carboplatin chemotherapy
boolean
C0008838 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0079083 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
EGFR Targeted Therapy Previous
Item
7. prior egfr targeted therapy of any kind
boolean
C0034802 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Operative Surgical Procedure Area affected | Exception Biopsy
Item
8. primary surgery to the affected area (excisional biopsy allowed)
boolean
C0543467 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
9. peripheral neuropathy > /= grade 2 (ctcae v4.0)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Sensorineural Hearing Impairment CTCAE Grades
Item
10. sensori-neural hearing impairment >= grade 2 (ctcae v4.0, hearing impaired, not enrolled on a monitoring program) which may be exacerbated by cisplatin (audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion)
boolean
C0018784 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Tinnitus CTCAE Grades
Item
11. tinnitus > /= grade 2 (ctcae v4.0)
boolean
C0040264 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Lung Disease, Interstitial | Interstitial Lung Disease CT
Item
12. history of interstitial lung disease or evidence of interstitial lung disease on pre-registration ct
boolean
C0206062 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Myocardial Infarction | Congestive heart failure Uncontrolled | Angina, Unstable | Cardiomyopathy | Cardiac Arrhythmia Unstable | Psychotic Disorders Uncontrolled | Communicable Diseases Serious | Peptic Ulcer | Immunosuppression Post Organ Transplantation | Immunosuppressive Agents Autoimmune Diseases
Item
13. history of myocardial infarction within 12 months prior to study entry, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled psychotic disorders, active serious infections, active peptic ulcer disease, immunosuppression due to post-organ transplantation or use of immunosuppressants for autoimmune disorders
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0878544 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0033975 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0030920 (UMLS CUI [8])
C4048329 (UMLS CUI [9,1])
C0687676 (UMLS CUI [9,2])
C0029216 (UMLS CUI [9,3])
C0021081 (UMLS CUI [10,1])
C0004364 (UMLS CUI [10,2])
HIV Seropositivity
Item
14. patients known to be hiv positive
boolean
C0019699 (UMLS CUI [1])
Cancer Other
Item
15. other cancer that was diagnosed:
boolean
C1707251 (UMLS CUI [1])
Disease recurrence | Disease recurrence Expected
Item
1. more than 5 years prior to current diagnosis with (i) subsequent evidence of disease recurrence or (ii) clinical expectation of recurrence is greater than 10% or
boolean
C0679254 (UMLS CUI [1])
C0679254 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Malignant melanoma in situ Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
2. within 5 years of the current diagnosis, with the exception of successfully treated basal cell or squamous cell skin carcinoma, in situ melanoma, or carcinoma in situ of the cervix
boolean
C1705847 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0854696 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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