ID

36998

Description

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02388932

Link

https://clinicaltrials.gov/show/NCT02388932

Keywords

Versions (1)
  1. 6/27/19 6/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Recurrent Hypopharyngeal Squamous Cell Carcinoma NCT02388932

English

Eligibility Recurrent Hypopharyngeal Squamous Cell Carcinoma NCT02388932

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient must have squamous cell carcinoma proven by histologic diagnosis; for cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16 staining is not required
Description

Squamous cell carcinoma | Oropharyngeal Carcinoma Immunohistochemistry Negative | P16 Staining Immunohistochemistry | Carcinoma of larynx | Hypopharyngeal Carcinoma | Oral Cavity Carcinoma | Nasopharyngeal carcinoma | Paranasal Sinus Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0007137
UMLS CUI [2,1]
C2349952
UMLS CUI [2,2]
C0021044
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C2354136
UMLS CUI [3,2]
C0487602
UMLS CUI [3,3]
C0021044
UMLS CUI [4]
C0595989
UMLS CUI [5]
C1368404
UMLS CUI [6]
C0151546
UMLS CUI [7]
C2931822
UMLS CUI [8]
C0854995
the patient must have clinical stage t1-4, n0-3, m0-1, stage ii-ivc carcinoma as per the 7th edition of the american joint committee on cancer (ajcc) staging manual; patients with t1n0m0 or t2n0m0 will be ineligible; patients with metastatic disease with a limited metastatic burden are eligible if obtaining local control is determined by their treating oncologist to be an important therapeutic goal
Description

Carcinoma TNM clinical staging | Neoplasm Metastasis Burden Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1449699
UMLS CUI [2,3]
C0439801
the patient must have imaging documenting a primary tumor, or involved lymph node, >= 2.5 cm in greatest dimension
Description

Primary tumor Longest Diameter Imaging | Lymph Node Involvement Longest Diameter Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0552406
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C0806692
UMLS CUI [2,2]
C0552406
UMLS CUI [2,3]
C0011923
pet/ct is required for all patients, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to sbrt planning
Description

PET/CT Required | Exception Medical contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C1699633
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1301624
the patient must have a history and physical documented within four weeks of registration and be deemed by a medical oncologist to be ineligible for standard continuous course chemoradiotherapy with cisplatin
Description

Patient Ineligible Cisplatin Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0008838
UMLS CUI [1,4]
C0392920
karnofsky performance status (ps) >= 40
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
female patients cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months
Description

Childbearing Potential Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
patients must have the ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with t1n0m0 stage i disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
patients who are receiving any other investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients with non-squamous cell histology
Description

Non-squamous cell Histology

Data type

boolean

Alias
UMLS CUI [1,1]
C1545484
UMLS CUI [1,2]
C0344441
patients with life expectancy < 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients who cannot lie flat for 20 minutes
Description

Lacking Able to maintain a lying position Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C4075030
UMLS CUI [1,3]
C0449238
patients with prior history of head and neck radiotherapy (> 40 gy) with significant areas of anticipated overlap
Description

Radiotherapy to head and neck

Data type

boolean

Alias
UMLS CUI [1]
C3888854
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Similar models

Eligibility Recurrent Hypopharyngeal Squamous Cell Carcinoma NCT02388932

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma | Oropharyngeal Carcinoma Immunohistochemistry Negative | P16 Staining Immunohistochemistry | Carcinoma of larynx | Hypopharyngeal Carcinoma | Oral Cavity Carcinoma | Nasopharyngeal carcinoma | Paranasal Sinus Cancer
Item
the patient must have squamous cell carcinoma proven by histologic diagnosis; for cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16 staining is not required
boolean
C0007137 (UMLS CUI [1])
C2349952 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C2354136 (UMLS CUI [3,1])
C0487602 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
C0595989 (UMLS CUI [4])
C1368404 (UMLS CUI [5])
C0151546 (UMLS CUI [6])
C2931822 (UMLS CUI [7])
C0854995 (UMLS CUI [8])
Carcinoma TNM clinical staging | Neoplasm Metastasis Burden Limited
Item
the patient must have clinical stage t1-4, n0-3, m0-1, stage ii-ivc carcinoma as per the 7th edition of the american joint committee on cancer (ajcc) staging manual; patients with t1n0m0 or t2n0m0 will be ineligible; patients with metastatic disease with a limited metastatic burden are eligible if obtaining local control is determined by their treating oncologist to be an important therapeutic goal
boolean
C0007097 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1449699 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Primary tumor Longest Diameter Imaging | Lymph Node Involvement Longest Diameter Imaging
Item
the patient must have imaging documenting a primary tumor, or involved lymph node, >= 2.5 cm in greatest dimension
boolean
C0677930 (UMLS CUI [1,1])
C0552406 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0806692 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
PET/CT Required | Exception Medical contraindication
Item
pet/ct is required for all patients, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to sbrt planning
boolean
C1699633 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
Patient Ineligible Cisplatin Chemotherapy
Item
the patient must have a history and physical documented within four weeks of registration and be deemed by a medical oncologist to be ineligible for standard continuous course chemoradiotherapy with cisplatin
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0008838 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
Karnofsky Performance Status
Item
karnofsky performance status (ps) >= 40
boolean
C0206065 (UMLS CUI [1])
Childbearing Potential Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
female patients cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
patients must have the ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease TNM clinical staging
Item
patients with t1n0m0 stage i disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Investigational New Drugs
Item
patients who are receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Non-squamous cell Histology
Item
patients with non-squamous cell histology
boolean
C1545484 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
Life Expectancy
Item
patients with life expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Lacking Able to maintain a lying position Duration
Item
patients who cannot lie flat for 20 minutes
boolean
C0332268 (UMLS CUI [1,1])
C4075030 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Radiotherapy to head and neck
Item
patients with prior history of head and neck radiotherapy (> 40 gy) with significant areas of anticipated overlap
boolean
C3888854 (UMLS CUI [1])
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