ID

15284

Beschrijving

Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00176800

Link

https://clinicaltrials.gov/show/NCT00176800

Trefwoorden

Versies (1)
  1. 24-05-16 24-05-16 -
Geüploaded op

24 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Esophageal Carcinoma NCT00176800

Engels

Eligibility Esophageal Carcinoma NCT00176800

1 Formulieren  
Criteria
Beschrijving

Criteria

1. histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
Beschrijving

adenocarcinoma or squamous cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0001418
UMLS CUI [2]
C0279626
UMLS CUI [3]
C0014871
2. no prior treatment for the esophageal cancer allowed.
Beschrijving

treatment for the esophageal cance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0014859
3. no prior thoracic or upper abdominal radiation.
Beschrijving

thoracic or upper abdominal radiation

Datatype

boolean

Alias
UMLS CUI [1]
C0851346
4. disease should be limited to the esophagus and regional lymph nodes. regional lymph nodes are described in section 4.0. however, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
Beschrijving

disease should be limited to the esophagus

Datatype

boolean

Alias
UMLS CUI [1]
C2063953
5. disease must be able to be encompassed in a single radiation field.
Beschrijving

single radiation field

Datatype

boolean

Alias
UMLS CUI [1]
C1882536
6. no medical contraindication to surgery
Beschrijving

contraindication to surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0852649
7. all treatment is to be administered at the university of michigan medical center.
Beschrijving

administered at the university of michigan medical center

Datatype

boolean

Alias
UMLS CUI [1]
C2347790
8. karnofsky performance status > 70 %.
Beschrijving

karnofsky performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
9. age range: 18 - 75 years old.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
10. adequate baseline hematopoetic function:
Beschrijving

hematopoetic function

Datatype

boolean

Alias
UMLS CUI [1]
C0018951
platelet count equal to or greater than 100,000/mm3 absolute granulocyte count equal to or greater than 1500/mm3 hematocrit equal to or greater than 29% (patients may be transfused to this level)
Beschrijving

platelet count

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0518014
11. adequate baseline organ function :
Beschrijving

organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
creatinine clearance >/= 60 mls/min bilirubin equal to or less than 1.5 x upper limits of normal ast/alt equal to or less than 2.5 x upper limits of normal
Beschrijving

creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C1557209
UMLS CUI [3]
C0364051
12. patients with any complaint of hearing loss should be evaluated with an audiogram. the average pure tone average hearing loss from 500-2000hz should not exceed 30 db. if it does, the patient should be warned that further hearing loss may be very noticeable and permanent.
Beschrijving

hearing loss

Datatype

boolean

Alias
UMLS CUI [1]
C3887873
13. prior malignancy is acceptable if the patient is considered to be cured. in most cases this will mean a 5-year disease-free period. contact the principal investigator for any specific question regarding this requirement.
Beschrijving

prior malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
14. patients with active infection, serious inter-current medical conditions are ineligible, according to the judgment of the investigators.
Beschrijving

active infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0009488
15. pregnant or lactating females are not eligible. women of childbearing potential must be using contraception throughout the entire period of treatment.
Beschrijving

pregnant or lactating women

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
16. ability to give informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Esophageal Carcinoma NCT00176800

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
adenocarcinoma or squamous cell carcinoma
Item
1. histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
boolean
C0001418 (UMLS CUI [1])
C0279626 (UMLS CUI [2])
C0014871 (UMLS CUI [3])
treatment for the esophageal cance
Item
2. no prior treatment for the esophageal cancer allowed.
boolean
C0087111 (UMLS CUI [1,1])
C0014859 (UMLS CUI [1,2])
thoracic or upper abdominal radiation
Item
3. no prior thoracic or upper abdominal radiation.
boolean
C0851346 (UMLS CUI [1])
disease should be limited to the esophagus
Item
4. disease should be limited to the esophagus and regional lymph nodes. regional lymph nodes are described in section 4.0. however, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
boolean
C2063953 (UMLS CUI [1])
single radiation field
Item
5. disease must be able to be encompassed in a single radiation field.
boolean
C1882536 (UMLS CUI [1])
contraindication to surgery
Item
6. no medical contraindication to surgery
boolean
C0852649 (UMLS CUI [1])
administered at the university of michigan medical center
Item
7. all treatment is to be administered at the university of michigan medical center.
boolean
C2347790 (UMLS CUI [1])
karnofsky performance status
Item
8. karnofsky performance status > 70 %.
boolean
C0206065 (UMLS CUI [1])
age
Item
9. age range: 18 - 75 years old.
boolean
C0001779 (UMLS CUI [1])
hematopoetic function
Item
10. adequate baseline hematopoetic function:
boolean
C0018951 (UMLS CUI [1])
platelet count
Item
platelet count equal to or greater than 100,000/mm3 absolute granulocyte count equal to or greater than 1500/mm3 hematocrit equal to or greater than 29% (patients may be transfused to this level)
boolean
C0005821 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0518014 (UMLS CUI [3])
organ function
Item
11. adequate baseline organ function :
boolean
C0678852 (UMLS CUI [1])
creatinine clearance
Item
creatinine clearance >/= 60 mls/min bilirubin equal to or less than 1.5 x upper limits of normal ast/alt equal to or less than 2.5 x upper limits of normal
boolean
C0373595 (UMLS CUI [1])
C1557209 (UMLS CUI [2])
C0364051 (UMLS CUI [3])
hearing loss
Item
12. patients with any complaint of hearing loss should be evaluated with an audiogram. the average pure tone average hearing loss from 500-2000hz should not exceed 30 db. if it does, the patient should be warned that further hearing loss may be very noticeable and permanent.
boolean
C3887873 (UMLS CUI [1])
prior malignancy
Item
13. prior malignancy is acceptable if the patient is considered to be cured. in most cases this will mean a 5-year disease-free period. contact the principal investigator for any specific question regarding this requirement.
boolean
C0006826 (UMLS CUI [1])
active infection
Item
14. patients with active infection, serious inter-current medical conditions are ineligible, according to the judgment of the investigators.
boolean
C0009450 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
pregnant or lactating women
Item
15. pregnant or lactating females are not eligible. women of childbearing potential must be using contraception throughout the entire period of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
informed consent
Item
16. ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
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