ID

37433

Beschrijving

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02499120

Link

https://clinicaltrials.gov/show/NCT02499120

Trefwoorden

Versies (1)
  1. 26-07-19 26-07-19 -
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See clinicaltrials.gov

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26 juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02499120

Engels

Eligibility Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02499120

1 Formulieren  
Criteria
Beschrijving

Criteria

histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
Beschrijving

Squamous cell carcinoma of mouth | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Salvage procedure Unsuccessful | Therapeutic radiology procedure Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C0585362
UMLS CUI [2]
C0280313
UMLS CUI [3]
C0280321
UMLS CUI [4]
C0280324
UMLS CUI [5,1]
C0442967
UMLS CUI [5,2]
C1272705
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C1272705
measurable disease as defined per recist v. 1.1. tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
hpv- negative scchn tumor as determined per institutional standard (eg, p16 ihc; multiplex nucleic acid sequence based amplification [nasba] or other polymerase chain reaction [pcr]-based assays).
Beschrijving

Squamous cell carcinoma of the head and neck HPV Negative P16 Immunohistochemistry | Squamous cell carcinoma of the head and neck HPV Negative NASBA | Squamous cell carcinoma of the head and neck HPV Negative Polymerase Chain Reaction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C4330331
UMLS CUI [1,3]
C2354136
UMLS CUI [1,4]
C0021044
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C4330331
UMLS CUI [2,3]
C0969664
UMLS CUI [3,1]
C1168401
UMLS CUI [3,2]
C4330331
UMLS CUI [3,3]
C0032520
documented progressive disease according to recist v1.1 (appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for r/m disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [auc] > 4 for carboplatin).
Beschrijving

Progressive Disease | Chemotherapy cycle Platinum-Based Quantity | Cisplatin | Carboplatin

Datatype

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0008838
UMLS CUI [4]
C0079083
availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. if archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
Beschrijving

Availability of Tumor tissue sample | Formalin-fixed paraffin-embedded tissue specimen | Unstained Specimen | Biomarker Analysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C2711483
UMLS CUI [3]
C1883469
UMLS CUI [4]
C1879847
key exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior nasopharyngeal cancer, salivary gland or sinus tumors.
Beschrijving

Nasopharyngeal carcinoma | Salivary Gland Neoplasms | Malignant tumor of nasal sinuses

Datatype

boolean

Alias
UMLS CUI [1]
C2931822
UMLS CUI [2]
C0036095
UMLS CUI [3]
C0153474
more than one chemotherapeutic regimen given for r/m disease. prior treatment with immunotherapy is allowed.
Beschrijving

Chemotherapy Regimen Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
known active uncontrolled or symptomatic central nervous system (cns) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. patients with a history of cns metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
Beschrijving

CNS metastases Uncontrolled | CNS metastases Symptomatic | Meningeal Carcinomatosis | Leptomeningeal Neoplasms | Symptoms Clinical | Cerebral Edema | Growth Progressive | Local Therapy CNS metastases allowed | Local Therapy Compression of spinal cord allowed | Therapeutic radiology procedure | Stereotactic surgery | Anticonvulsants Absent | Steroids Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0220654
UMLS CUI [4]
C0751297
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0205210
UMLS CUI [6]
C0006114
UMLS CUI [7,1]
C0220844
UMLS CUI [7,2]
C0205329
UMLS CUI [8,1]
C1517925
UMLS CUI [8,2]
C0686377
UMLS CUI [8,3]
C0683607
UMLS CUI [9,1]
C1517925
UMLS CUI [9,2]
C0037926
UMLS CUI [9,3]
C0683607
UMLS CUI [10]
C1522449
UMLS CUI [11]
C1735594
UMLS CUI [12,1]
C0003286
UMLS CUI [12,2]
C0332197
UMLS CUI [13,1]
C0038317
UMLS CUI [13,2]
C0332197
progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced scchn.
Beschrijving

Progressive Disease | Status post Curative treatment Completion | Squamous cell carcinoma of the head and neck Advanced Locoregional

Datatype

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C1168401
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1947913
difficulty swallowing capsules or requirement for a feeding tube.
Beschrijving

Difficulty with Swallowing Capsules | Requirement Feeding tube

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C4521686
UMLS CUI [1,3]
C0006935
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C2945625
prior use of cetuximab in the r/m disease treatment setting (except cetuximab during curative radiotherapy)
Beschrijving

cetuximab

Datatype

boolean

Alias
UMLS CUI [1]
C0995188
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Similar models

Eligibility Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02499120

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Squamous cell carcinoma of mouth | Squamous cell carcinoma of oropharynx | Squamous cell carcinoma of the hypopharynx | Laryngeal Squamous Cell Carcinoma | Salvage procedure Unsuccessful | Therapeutic radiology procedure Unsuccessful
Item
histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
boolean
C0585362 (UMLS CUI [1])
C0280313 (UMLS CUI [2])
C0280321 (UMLS CUI [3])
C0280324 (UMLS CUI [4])
C0442967 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
Measurable Disease
Item
measurable disease as defined per recist v. 1.1. tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.
boolean
C1513041 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck HPV Negative P16 Immunohistochemistry | Squamous cell carcinoma of the head and neck HPV Negative NASBA | Squamous cell carcinoma of the head and neck HPV Negative Polymerase Chain Reaction
Item
hpv- negative scchn tumor as determined per institutional standard (eg, p16 ihc; multiplex nucleic acid sequence based amplification [nasba] or other polymerase chain reaction [pcr]-based assays).
boolean
C1168401 (UMLS CUI [1,1])
C4330331 (UMLS CUI [1,2])
C2354136 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
C1168401 (UMLS CUI [2,1])
C4330331 (UMLS CUI [2,2])
C0969664 (UMLS CUI [2,3])
C1168401 (UMLS CUI [3,1])
C4330331 (UMLS CUI [3,2])
C0032520 (UMLS CUI [3,3])
Progressive Disease | Chemotherapy cycle Platinum-Based Quantity | Cisplatin | Carboplatin
Item
documented progressive disease according to recist v1.1 (appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for r/m disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [auc] > 4 for carboplatin).
boolean
C1335499 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0008838 (UMLS CUI [3])
C0079083 (UMLS CUI [4])
Availability of Tumor tissue sample | Formalin-fixed paraffin-embedded tissue specimen | Unstained Specimen | Biomarker Analysis
Item
availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. if archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C1883469 (UMLS CUI [3])
C1879847 (UMLS CUI [4])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Nasopharyngeal carcinoma | Salivary Gland Neoplasms | Malignant tumor of nasal sinuses
Item
prior nasopharyngeal cancer, salivary gland or sinus tumors.
boolean
C2931822 (UMLS CUI [1])
C0036095 (UMLS CUI [2])
C0153474 (UMLS CUI [3])
Chemotherapy Regimen Quantity
Item
more than one chemotherapeutic regimen given for r/m disease. prior treatment with immunotherapy is allowed.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
CNS metastases Uncontrolled | CNS metastases Symptomatic | Meningeal Carcinomatosis | Leptomeningeal Neoplasms | Symptoms Clinical | Cerebral Edema | Growth Progressive | Local Therapy CNS metastases allowed | Local Therapy Compression of spinal cord allowed | Therapeutic radiology procedure | Stereotactic surgery | Anticonvulsants Absent | Steroids Absent
Item
known active uncontrolled or symptomatic central nervous system (cns) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. patients with a history of cns metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220654 (UMLS CUI [3])
C0751297 (UMLS CUI [4])
C1457887 (UMLS CUI [5,1])
C0205210 (UMLS CUI [5,2])
C0006114 (UMLS CUI [6])
C0220844 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C1517925 (UMLS CUI [8,1])
C0686377 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
C1517925 (UMLS CUI [9,1])
C0037926 (UMLS CUI [9,2])
C0683607 (UMLS CUI [9,3])
C1522449 (UMLS CUI [10])
C1735594 (UMLS CUI [11])
C0003286 (UMLS CUI [12,1])
C0332197 (UMLS CUI [12,2])
C0038317 (UMLS CUI [13,1])
C0332197 (UMLS CUI [13,2])
Progressive Disease | Status post Curative treatment Completion | Squamous cell carcinoma of the head and neck Advanced Locoregional
Item
progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced scchn.
boolean
C1335499 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1168401 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1947913 (UMLS CUI [3,3])
Difficulty with Swallowing Capsules | Requirement Feeding tube
Item
difficulty swallowing capsules or requirement for a feeding tube.
boolean
C0332218 (UMLS CUI [1,1])
C4521686 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C2945625 (UMLS CUI [2,2])
cetuximab
Item
prior use of cetuximab in the r/m disease treatment setting (except cetuximab during curative radiotherapy)
boolean
C0995188 (UMLS CUI [1])
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