ID

31250

Beschreibung

Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01772706

Link

https://clinicaltrials.gov/show/NCT01772706

Stichworte

Versionen (1)
  1. 02.08.18 02.08.18 -
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See clinicaltrials.gov

Hochgeladen am

2. August 2018

DOI

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Eligibility Oral Squamous Cell Carcinoma NCT01772706

Englisch

Eligibility Oral Squamous Cell Carcinoma NCT01772706

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age between 18 and 75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage iii-iv, histologically confirmed
Beschreibung

Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0585362
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0280313
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0280321
UMLS CUI [3,2]
C3258246
3. ps > or = 2
Beschreibung

Performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
4. estimated life expectancy greater than 3 months in the absence of treatment
Beschreibung

Life Expectancy | Therapeutic procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332197
5. concomitant chemotherapy with one of the following choices not prohibited:
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
cetuximab alone
Beschreibung

cetuximab

Datentyp

boolean

Alias
UMLS CUI [1]
C0995188
5-fu combined to carboplatin or cisplatin
Beschreibung

Fluorouracil | Combined Modality Therapy | Carboplatin | Cisplatin

Datentyp

boolean

Alias
UMLS CUI [1]
C0016360
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0079083
UMLS CUI [4]
C0008838
cisplatin alone being defined as follows: serum creatinine < 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the cockcroft method) in case of serum creatinine > 120 µmol/l
Beschreibung

Cisplatin | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0008838
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
6. appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
hemoglobin> 8g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
neutrophils> 1500 x 109 / l
Beschreibung

Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
platelets> 100 x 109 / l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin <1.5 times the upper limit of normal
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
alt / ast and alkaline phosphatase <2.5 times the upper limit of normal.
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201850
7. for women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.
Beschreibung

Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0021900
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
Beschreibung

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
2. neoadjuvant chemotherapy
Beschreibung

Chemotherapy Neoadjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
3. metastatic disease
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
4. previous treatment with ent radiotherapy
Beschreibung

Radiotherapy to head and neck

Datentyp

boolean

Alias
UMLS CUI [1]
C3888854
5. severe hypersensitivity known to platinum based agent
Beschreibung

Severe allergy Platinum-based Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C2266918
6. any uncontrolled pathology (respiratory, cardiac, hepatic or renal)
Beschreibung

Pathology Uncontrolled | Respiration Disorder Uncontrolled | Heart Disease Uncontrolled | Liver disease Uncontrolled | Kidney Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205318
7. pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
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Ähnliche Modelle

Eligibility Oral Squamous Cell Carcinoma NCT01772706

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age between 18 and 75 years
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging
Item
2. patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage iii-iv, histologically confirmed
boolean
C0585362 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0280313 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0280321 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Performance status
Item
3. ps > or = 2
boolean
C1518965 (UMLS CUI [1])
Life Expectancy | Therapeutic procedure Absent
Item
4. estimated life expectancy greater than 3 months in the absence of treatment
boolean
C0023671 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Chemotherapy
Item
5. concomitant chemotherapy with one of the following choices not prohibited:
boolean
C0392920 (UMLS CUI [1])
cetuximab
Item
cetuximab alone
boolean
C0995188 (UMLS CUI [1])
Fluorouracil | Combined Modality Therapy | Carboplatin | Cisplatin
Item
5-fu combined to carboplatin or cisplatin
boolean
C0016360 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0079083 (UMLS CUI [3])
C0008838 (UMLS CUI [4])
Cisplatin | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
cisplatin alone being defined as follows: serum creatinine < 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the cockcroft method) in case of serum creatinine > 120 µmol/l
boolean
C0008838 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Hematologic function | Renal function | Liver function
Item
6. appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Hemoglobin measurement
Item
hemoglobin> 8g/dl
boolean
C0518015 (UMLS CUI [1])
Neutrophil count
Item
neutrophils> 1500 x 109 / l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelets> 100 x 109 / l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin <1.5 times the upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
alt / ast and alkaline phosphatase <2.5 times the upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices
Item
7. for women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
1. presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Chemotherapy Neoadjuvant
Item
2. neoadjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
3. metastatic disease
boolean
C0027627 (UMLS CUI [1])
Radiotherapy to head and neck
Item
4. previous treatment with ent radiotherapy
boolean
C3888854 (UMLS CUI [1])
Severe allergy Platinum-based Drug
Item
5. severe hypersensitivity known to platinum based agent
boolean
C2945656 (UMLS CUI [1,1])
C2266918 (UMLS CUI [1,2])
Pathology Uncontrolled | Respiration Disorder Uncontrolled | Heart Disease Uncontrolled | Liver disease Uncontrolled | Kidney Disease Uncontrolled
Item
6. any uncontrolled pathology (respiratory, cardiac, hepatic or renal)
boolean
C0677042 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
7. pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
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