ID

15978

Description

Hypofractionated Radiation Therapy Followed by Surgery in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity; ODM derived from: https://clinicaltrials.gov/show/NCT02295540

Link

https://clinicaltrials.gov/show/NCT02295540

Keywords

Versions (1)
  1. 6/23/16 6/23/16 -
Uploaded on

June 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity NCT02295540

English

Eligibility Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity NCT02295540

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is willing to sign study specific informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
Description

Squamous cell carcinoma | Papillary squamous cell carcinoma | Basaloid squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007137
UMLS CUI [2]
C0334244
UMLS CUI [3]
C1266005
advanced stage but not metastatic scc of the oral cavity (iii or iva, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head & neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ent)/radiation oncology
Description

Squamous cell carcinoma of mouth Advanced | TNM clinical staging | Tongue | Sublingual Region | Hard Palate | Gingiva | Buccal mucosa | Structure of retromolar area of mouth | Head and Neck Neoplasms | Oropharyngeal | Tumor of ear, nose and throat | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0585362
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0040408
UMLS CUI [4]
C0026638
UMLS CUI [5]
C0226901
UMLS CUI [6]
C0017562
UMLS CUI [7]
C1578559
UMLS CUI [8]
C0226920
UMLS CUI [9]
C0018671
UMLS CUI [10]
C0521367
UMLS CUI [11]
C0345616
UMLS CUI [12]
C1522449
patient is deemed to be a surgical candidate by ent
Description

Indication Ear, nose and throat surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1274038
karnofsky performance status (kps) 0-2
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
for women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy
Description

Childbearing Potential Serum pregnancy test negative | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C1522449
patients with human immunodeficiency virus (hiv) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation 4 (cd4) count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral therapy (haart) is allowed
Description

HIV Infections | CD4 Count determination procedure | Viral load measurement | Antiretroviral Therapy, Highly Active

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0243009
UMLS CUI [3]
C1261478
UMLS CUI [4]
C0887947
patient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 years
Description

invasive cancer Previous Free of | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332296
UMLS CUI [2]
C0699893
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (pet)/ct or biopsy
Description

Metastatic Neoplasm outside Neck | Metastatic Neoplasm outside Supraclavicular region of neck | PET/CT scan | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0205101
UMLS CUI [1,3]
C0027530
UMLS CUI [2,1]
C2939420
UMLS CUI [2,2]
C0205101
UMLS CUI [2,3]
C0230078
UMLS CUI [3]
C1699633
UMLS CUI [4]
C0005558
kps 3 or worse
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
gross disease in the retrostyloid (high level ii) or retropharyngeal lymph node regions by ct or pet/ct
Description

Malignant tumor of parapharyngeal space | Neoplasm of retropharyngeal lymph nodes | X-Ray Computed Tomography | PET/CT scan

Data type

boolean

Alias
UMLS CUI [1]
C0345756
UMLS CUI [2]
C1264204
UMLS CUI [3]
C0040405
UMLS CUI [4]
C1699633
patients may not have received previous therapy for their head and neck scc, including chemotherapy, radiation therapy, or surgery beyond biopsy
Description

Squamous cell carcinoma of the head and neck | Prior Therapy Absent | Chemotherapy Regimen | Therapeutic radiology procedure | Operative Surgical Procedures outside Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0205101
UMLS CUI [5,3]
C0005558
second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
Description

Second Primary Cancer | Therapeutic procedure | Disease Free of | Carcinoma in Situ | Carcinoma in situ of uterine cervix | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0087111
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
UMLS CUI [4]
C0007099
UMLS CUI [5]
C0851140
UMLS CUI [6]
C0699893
serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
Description

Systemic disease Simultaneous Serious At risk patient safety | Systemic disease Simultaneous Serious Compliance behavior Limited | Communicable Diseases At risk patient safety | Communicable Diseases Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0521115
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C1444641
UMLS CUI [1,5]
C1113679
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0521115
UMLS CUI [2,3]
C0205404
UMLS CUI [2,4]
C1321605
UMLS CUI [2,5]
C0439801
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C1321605
UMLS CUI [4,3]
C0439801
women who are pregnant; women of childbearing age must agree to undergo a urine pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Description

Pregnancy | Childbearing Potential Age Urine pregnancy test | Childbearing Potential Age Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0430056
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0001779
UMLS CUI [3,3]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0036899
patient is deemed to not be a surgical candidate by ent
Description

Medical contraindication Ear, nose and throat surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1274038
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Similar models

Eligibility Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity NCT02295540

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
patient is willing to sign study specific informed consent
boolean
C0021430 (UMLS CUI [1])
Squamous cell carcinoma | Papillary squamous cell carcinoma | Basaloid squamous cell carcinoma
Item
pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
boolean
C0007137 (UMLS CUI [1])
C0334244 (UMLS CUI [2])
C1266005 (UMLS CUI [3])
Squamous cell carcinoma of mouth Advanced | TNM clinical staging | Tongue | Sublingual Region | Hard Palate | Gingiva | Buccal mucosa | Structure of retromolar area of mouth | Head and Neck Neoplasms | Oropharyngeal | Tumor of ear, nose and throat | Therapeutic radiology procedure
Item
advanced stage but not metastatic scc of the oral cavity (iii or iva, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head & neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ent)/radiation oncology
boolean
C0585362 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0040408 (UMLS CUI [3])
C0026638 (UMLS CUI [4])
C0226901 (UMLS CUI [5])
C0017562 (UMLS CUI [6])
C1578559 (UMLS CUI [7])
C0226920 (UMLS CUI [8])
C0018671 (UMLS CUI [9])
C0521367 (UMLS CUI [10])
C0345616 (UMLS CUI [11])
C1522449 (UMLS CUI [12])
Indication Ear, nose and throat surgery
Item
patient is deemed to be a surgical candidate by ent
boolean
C3146298 (UMLS CUI [1,1])
C1274038 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
karnofsky performance status (kps) 0-2
boolean
C0206065 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Therapeutic radiology procedure
Item
for women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
HIV Infections | CD4 Count determination procedure | Viral load measurement | Antiretroviral Therapy, Highly Active
Item
patients with human immunodeficiency virus (hiv) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation 4 (cd4) count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral therapy (haart) is allowed
boolean
C0019693 (UMLS CUI [1])
C0243009 (UMLS CUI [2])
C1261478 (UMLS CUI [3])
C0887947 (UMLS CUI [4])
invasive cancer Previous Free of | Skin carcinoma
Item
patient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 years
boolean
C0677898 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0699893 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metastatic Neoplasm outside Neck | Metastatic Neoplasm outside Supraclavicular region of neck | PET/CT scan | Biopsy
Item
metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (pet)/ct or biopsy
boolean
C2939420 (UMLS CUI [1,1])
C0205101 (UMLS CUI [1,2])
C0027530 (UMLS CUI [1,3])
C2939420 (UMLS CUI [2,1])
C0205101 (UMLS CUI [2,2])
C0230078 (UMLS CUI [2,3])
C1699633 (UMLS CUI [3])
C0005558 (UMLS CUI [4])
Karnofsky Performance Status
Item
kps 3 or worse
boolean
C0206065 (UMLS CUI [1])
Malignant tumor of parapharyngeal space | Neoplasm of retropharyngeal lymph nodes | X-Ray Computed Tomography | PET/CT scan
Item
gross disease in the retrostyloid (high level ii) or retropharyngeal lymph node regions by ct or pet/ct
boolean
C0345756 (UMLS CUI [1])
C1264204 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C1699633 (UMLS CUI [4])
Squamous cell carcinoma of the head and neck | Prior Therapy Absent | Chemotherapy Regimen | Therapeutic radiology procedure | Operative Surgical Procedures outside Biopsy
Item
patients may not have received previous therapy for their head and neck scc, including chemotherapy, radiation therapy, or surgery beyond biopsy
boolean
C1168401 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5,1])
C0205101 (UMLS CUI [5,2])
C0005558 (UMLS CUI [5,3])
Second Primary Cancer | Therapeutic procedure | Disease Free of | Carcinoma in Situ | Carcinoma in situ of uterine cervix | Skin carcinoma
Item
second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
boolean
C0751623 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0007099 (UMLS CUI [4])
C0851140 (UMLS CUI [5])
C0699893 (UMLS CUI [6])
Systemic disease Simultaneous Serious At risk patient safety | Systemic disease Simultaneous Serious Compliance behavior Limited | Communicable Diseases At risk patient safety | Communicable Diseases Compliance behavior Limited
Item
serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
boolean
C0442893 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C1113679 (UMLS CUI [1,5])
C0442893 (UMLS CUI [2,1])
C0521115 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C1321605 (UMLS CUI [2,4])
C0439801 (UMLS CUI [2,5])
C0009450 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C1321605 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Pregnancy | Childbearing Potential Age Urine pregnancy test | Childbearing Potential Age Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
women who are pregnant; women of childbearing age must agree to undergo a urine pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0430056 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C2985296 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
Medical contraindication Ear, nose and throat surgery
Item
patient is deemed to not be a surgical candidate by ent
boolean
C1301624 (UMLS CUI [1,1])
C1274038 (UMLS CUI [1,2])
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