ID

39344

Beschrijving

Paclitaxel, Carboplatin and Cetuximab (PCC) Versus Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC); ODM derived from: https://clinicaltrials.gov/show/NCT01154920

Link

https://clinicaltrials.gov/show/NCT01154920

Trefwoorden

Versies (1)
  1. 23-12-19 23-12-19 -
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See clinicaltrials.gov

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23 december 2019

DOI

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Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT01154920

Engels

Eligibility Head and Neck Squamous Cell Carcinoma NCT01154920

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
Beschrijving

Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of nasopharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0280313
UMLS CUI [2]
C0585362
UMLS CUI [3]
C0279698
UMLS CUI [4]
C0280321
UMLS CUI [5]
C0280324
2. biopsy material sufficient for hpv status determination available
Beschrijving

Biopsy Tissue material Sufficient | Human Papillomavirus Determination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0457457
UMLS CUI [1,3]
C0205410
UMLS CUI [2,1]
C0021344
UMLS CUI [2,2]
C1148554
3. patients should have stage iv disease, stage t0-4 n2b-2c/3 m0 (for nasopharynx patients, stage n1 is eligible). measurable disease in either the t or n site by recist is required.
Beschrijving

Disease TNM clinical staging | Measurable Disease Primary tumor Site | Measurable Disease Lymph node Site

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0677930
UMLS CUI [2,3]
C1515974
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0024204
UMLS CUI [3,3]
C1515974
4. patients with stage tx primary disease are eligible if there is n2b-c/3 lymphadenopathy
Beschrijving

Disease TNM clinical staging | Lymphadenopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0497156
5. ecog ps 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
6. age >/= 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
7. patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc >/= 1500 cells/mm^3 and platelet count >/= 100,000 cells/mm^3; adequate hepatic function with bilirubin </= uln (excluding gilbert's disease), ast and alt may be up to 2.5 x uln if alkaline phosphatase is normal. alkaline phosphatase may be up to 4 x uln if ast and alt are normal. in determining eligibility the more abnormal of the two values (ast or alt) should be used.
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Gilbert Disease Excluded | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6,1]
C0017551
UMLS CUI [6,2]
C0332196
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201850
8. creatinine clearance >/=40 ml/min determined by 24 hour collection or nomogram:crcl male = (140 - age) x (wt in kg)/serum cr x 72 or crcl female = 0.85 x (crcl male)
Beschrijving

Creatinine clearance measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0079399
9. patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
Beschrijving

Comorbidity Serious Absent | Comorbidity chronic Absent | Communicable Disease Absent | Communicable Disease Affecting Induction Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C3179010
10. patients must sign a study-specific informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. histology other than squamous cell carcinoma
Beschrijving

Histology Except Squamous cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0007137
2. proven distant metastases (below the clavicle) by clinical or radiographic measures
Beschrijving

Distant metastasis below Clavicle

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0542339
UMLS CUI [1,3]
C0008913
3. ecog>1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
4. prior chemotherapy, within the previous 3 years
Beschrijving

Prior Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
5. prior radiotherapy to the head and neck
Beschrijving

Radiation therapy to the head and neck

Datatype

boolean

Alias
UMLS CUI [1]
C4540910
6. prior cetuximab therapy or prior therapy with any other drug that targets the egfr pathway
Beschrijving

cetuximab | Targeted Therapy EGFR signaling pathway

Datatype

boolean

Alias
UMLS CUI [1]
C0995188
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1155379
7. initial surgical resection rendering the patient clinically and radiologically disease free
Beschrijving

Excision Initial | Patient Disease Free

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
8. simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
Beschrijving

Primary tumor Invasive Simultaneous | Exception Skin carcinoma Superficial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0521115
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C0205124
9. patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free
Beschrijving

Cancer Other | Exception Skin carcinoma | Exception Malignant Neoplasm Treated | Exception Disease Free

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
10. men and women of childbearing potential (wocbp) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
Beschrijving

Females & males of reproductive potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
11. women who are pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
12. pre-existing peripheral neuropathy ctcae grade 2 or worse
Beschrijving

Peripheral Neuropathy Pre-existing CTCAE grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
13. hemoglobin < 8.0g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
14. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Beschrijving

Severe allergy Docetaxel | Severe allergy Formulation Polysorbate 80

Datatype

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0524527
UMLS CUI [2,3]
C0032601
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT01154920

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of mouth | Squamous cell carcinoma of nasopharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma
Item
1. patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
boolean
C0280313 (UMLS CUI [1])
C0585362 (UMLS CUI [2])
C0279698 (UMLS CUI [3])
C0280321 (UMLS CUI [4])
C0280324 (UMLS CUI [5])
Biopsy Tissue material Sufficient | Human Papillomavirus Determination
Item
2. biopsy material sufficient for hpv status determination available
boolean
C0005558 (UMLS CUI [1,1])
C0457457 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
C0021344 (UMLS CUI [2,1])
C1148554 (UMLS CUI [2,2])
Disease TNM clinical staging | Measurable Disease Primary tumor Site | Measurable Disease Lymph node Site
Item
3. patients should have stage iv disease, stage t0-4 n2b-2c/3 m0 (for nasopharynx patients, stage n1 is eligible). measurable disease in either the t or n site by recist is required.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
Disease TNM clinical staging | Lymphadenopathy
Item
4. patients with stage tx primary disease are eligible if there is n2b-c/3 lymphadenopathy
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0497156 (UMLS CUI [2])
ECOG performance status
Item
5. ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
6. age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Gilbert Disease Excluded | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
7. patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc >/= 1500 cells/mm^3 and platelet count >/= 100,000 cells/mm^3; adequate hepatic function with bilirubin </= uln (excluding gilbert's disease), ast and alt may be up to 2.5 x uln if alkaline phosphatase is normal. alkaline phosphatase may be up to 4 x uln if ast and alt are normal. in determining eligibility the more abnormal of the two values (ast or alt) should be used.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0017551 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201850 (UMLS CUI [9])
Creatinine clearance measurement | Gender
Item
8. creatinine clearance >/=40 ml/min determined by 24 hour collection or nomogram:crcl male = (140 - age) x (wt in kg)/serum cr x 72 or crcl female = 0.85 x (crcl male)
boolean
C0373595 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Comorbidity Serious Absent | Comorbidity chronic Absent | Communicable Disease Absent | Communicable Disease Affecting Induction Chemotherapy
Item
9. patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C3179010 (UMLS CUI [4,3])
Informed Consent
Item
10. patients must sign a study-specific informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Histology Except Squamous cell carcinoma
Item
1. histology other than squamous cell carcinoma
boolean
C0344441 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0007137 (UMLS CUI [1,3])
Distant metastasis below Clavicle
Item
2. proven distant metastases (below the clavicle) by clinical or radiographic measures
boolean
C1269798 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C0008913 (UMLS CUI [1,3])
ECOG performance status
Item
3. ecog>1
boolean
C1520224 (UMLS CUI [1])
Prior Chemotherapy
Item
4. prior chemotherapy, within the previous 3 years
boolean
C1514457 (UMLS CUI [1])
Radiation therapy to the head and neck
Item
5. prior radiotherapy to the head and neck
boolean
C4540910 (UMLS CUI [1])
cetuximab | Targeted Therapy EGFR signaling pathway
Item
6. prior cetuximab therapy or prior therapy with any other drug that targets the egfr pathway
boolean
C0995188 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C1155379 (UMLS CUI [2,2])
Excision Initial | Patient Disease Free
Item
7. initial surgical resection rendering the patient clinically and radiologically disease free
boolean
C0728940 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Primary tumor Invasive Simultaneous | Exception Skin carcinoma Superficial
Item
8. simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
boolean
C0677930 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0205124 (UMLS CUI [2,3])
Cancer Other | Exception Skin carcinoma | Exception Malignant Neoplasm Treated | Exception Disease Free
Item
9. patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
10. men and women of childbearing potential (wocbp) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
11. women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy Pre-existing CTCAE grades
Item
12. pre-existing peripheral neuropathy ctcae grade 2 or worse
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Hemoglobin measurement
Item
13. hemoglobin < 8.0g/dl
boolean
C0518015 (UMLS CUI [1])
Severe allergy Docetaxel | Severe allergy Formulation Polysorbate 80
Item
14. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0032601 (UMLS CUI [2,3])
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