ID

13894

Description

A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.; ODM derived from: https://clinicaltrials.gov/show/NCT01427010

Link

https://clinicaltrials.gov/show/NCT01427010

Keywords

Versions (1)
  1. 3/13/16 3/13/16 -
Uploaded on

March 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor. NCT01427010

English

Eligibility Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor. NCT01427010

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
Description

recurrence squamous cell carcinoma of the oral cavity

Data type

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0585362
primary unresectable tumor and/or patients refused surgery.
Description

Tumor surgically unresectable

Data type

boolean

Alias
UMLS CUI [1]
C4039777
no grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
Description

late toxicity; xerostomia; Chemoradiotherapy; Cancer of Head and Neck

Data type

boolean

Alias
UMLS CUI [1]
C2198186
UMLS CUI [2]
C0043352
UMLS CUI [3]
C0436307
UMLS CUI [4]
C0278996
minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
Description

Chemoradiotherapy; Cancer of Head and Neck

Data type

boolean

Alias
UMLS CUI [1]
C0436307
UMLS CUI [2]
C0278996
decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
Description

radiotherapy; Targeted Therapy; cetuximab

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C2985566
UMLS CUI [3]
C0995188
karnofsky performance status ≥70%.
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
age ≥ 18 years old.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent obtained, signed and dated before specific protocol procedures.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous radiotherapy for ct1-2 cn0 m0 glottic cancer.
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
brachytherapy as treatment for second primary / recurrence.
Description

brachytherapy; recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0034897
distant metastases.
Description

metastases

Data type

boolean

Alias
UMLS CUI [1]
C0027627
other second primary tumors that are not under control.
Description

primary tumor

Data type

boolean

Alias
UMLS CUI [1]
C0677930
pregnant or lactating women.
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
elevated blood creatinine level.
Description

blood creatinine level

Data type

boolean

Alias
UMLS CUI [1]
C3516328
allergy to the ct-contrast agents.
Description

hypersensitivity contrast agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009924
mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
Description

Compliance behavior Limited mental condition

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3840291
patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor. NCT01427010

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
recurrence squamous cell carcinoma of the oral cavity
Item
histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
boolean
C0034897 (UMLS CUI [1,1])
C0585362 (UMLS CUI [1,2])
Tumor surgically unresectable
Item
primary unresectable tumor and/or patients refused surgery.
boolean
C4039777 (UMLS CUI [1])
late toxicity; xerostomia; Chemoradiotherapy; Cancer of Head and Neck
Item
no grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
boolean
C2198186 (UMLS CUI [1])
C0043352 (UMLS CUI [2])
C0436307 (UMLS CUI [3])
C0278996 (UMLS CUI [4])
Chemoradiotherapy; Cancer of Head and Neck
Item
minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
boolean
C0436307 (UMLS CUI [1])
C0278996 (UMLS CUI [2])
radiotherapy; Targeted Therapy; cetuximab
Item
decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
boolean
C1522449 (UMLS CUI [1])
C2985566 (UMLS CUI [2])
C0995188 (UMLS CUI [3])
karnofsky performance status
Item
karnofsky performance status ≥70%.
boolean
C0206065 (UMLS CUI [1])
age
Item
age ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
informed consent obtained, signed and dated before specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
radiotherapy
Item
previous radiotherapy for ct1-2 cn0 m0 glottic cancer.
boolean
C1522449 (UMLS CUI [1])
brachytherapy; recurrence
Item
brachytherapy as treatment for second primary / recurrence.
boolean
C0034897 (UMLS CUI [1])
metastases
Item
distant metastases.
boolean
C0027627 (UMLS CUI [1])
primary tumor
Item
other second primary tumors that are not under control.
boolean
C0677930 (UMLS CUI [1])
pregnancy; lactating
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
blood creatinine level
Item
elevated blood creatinine level.
boolean
C3516328 (UMLS CUI [1])
hypersensitivity contrast agent
Item
allergy to the ct-contrast agents.
boolean
C0020517 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
Compliance behavior Limited mental condition
Item
mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3840291 (UMLS CUI [1,3])
compliance
Item
patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
boolean
C1321605 (UMLS CUI [1])
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