ID

28353

Descrição

Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens; ODM derived from: https://clinicaltrials.gov/show/NCT00603577

Link

https://clinicaltrials.gov/show/NCT00603577

Palavras-chave

Versões (1)
  1. 06/01/2018 06/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de janeiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00603577

Inglês

Eligibility Colorectal Neoplasms NCT00603577

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
Descrição

Chemotherapy Containing Oxaliplatin Completed | Complete excision Colon tumor primary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0069717
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0015250
UMLS CUI [2,2]
C0009375
UMLS CUI [2,3]
C0205225
have grade ≥ 1 psn, as defined by the nci-ctcae version 3.0
Descrição

Peripheral sensory neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
have an ecog performance status ≤2;
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
blood tests within 14 days prior to randomization: (a) ast (sgot) and alt (sgpt) ≤2 uln; (b) serum creatinine ≤1.5xunl; (c)hba1c ≤7%; (d) neutrophils ≥1.5x10^9/l ; (e) platelets ≥50x10^9/l; (f) serum d-dimer within normal limits
Descrição

Hematologic Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Glucohemoglobin measurement | Neutrophil count | Platelet Count measurement | Fibrin D dimer normal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0202054
UMLS CUI [6]
C0200633
UMLS CUI [7]
C0032181
UMLS CUI [8]
C0855431
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-existing peripheral neuropathy prior to treatment with oxaliplatin
Descrição

Peripheral Neuropathy Pre-existing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
receiving any further anti-cancer treatment
Descrição

Cancer treatment Additional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1524062
history of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
Descrição

Thromboembolism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040038
unstable cardiac disease
Descrição

Heart Disease Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
history of significant neurological or psychiatric disorders including dementia or seizures,
Descrição

Nervous system disorder | Mental disorders | Dementia | Seizures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0036572
active uncontrolled infection
Descrição

Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
active disseminated intravascular coagulation
Descrição

Disseminated Intravascular Coagulation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012739
other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
Descrição

Comorbidity Serious Study Subject Participation Status Impaired

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0221099
use of antidepressant/antiepileptic medication (for the treatment of psn), unless commenced before informed consent form signed. the addition of these medications (for the treatment of psn) once the patient has consented is not allowed
Descrição

Antidepressive Agents Peripheral sensory neuropathy | Antiepileptic Agents Peripheral sensory neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0151313
UMLS CUI [2,1]
C0003299
UMLS CUI [2,2]
C0151313
concurrent treatment with any other experimental drugs
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or breast-feeding women;
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential must be protected by effective contraceptive methods of birth control. post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential
Descrição

Childbearing Potential Contraceptive methods | Postmenopausal state Amenorrhea Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0002453
UMLS CUI [2,3]
C0449238
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. those conditions should be assessed with the patient before registration in the trial.
Descrição

Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033898
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Colorectal Neoplasms NCT00603577

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chemotherapy Containing Oxaliplatin Completed | Complete excision Colon tumor primary
Item
have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
boolean
C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0069717 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0015250 (UMLS CUI [2,1])
C0009375 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Peripheral sensory neuropathy CTCAE Grades
Item
have grade ≥ 1 psn, as defined by the nci-ctcae version 3.0
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
ECOG performance status
Item
have an ecog performance status ≤2;
boolean
C1520224 (UMLS CUI [1])
Hematologic Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Glucohemoglobin measurement | Neutrophil count | Platelet Count measurement | Fibrin D dimer normal
Item
blood tests within 14 days prior to randomization: (a) ast (sgot) and alt (sgpt) ≤2 uln; (b) serum creatinine ≤1.5xunl; (c)hba1c ≤7%; (d) neutrophils ≥1.5x10^9/l ; (e) platelets ≥50x10^9/l; (f) serum d-dimer within normal limits
boolean
C0018941 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0202054 (UMLS CUI [5])
C0200633 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
C0855431 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy Pre-existing
Item
pre-existing peripheral neuropathy prior to treatment with oxaliplatin
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Cancer treatment Additional
Item
receiving any further anti-cancer treatment
boolean
C0920425 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Thromboembolism
Item
history of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
boolean
C0040038 (UMLS CUI [1])
Heart Disease Unstable
Item
unstable cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Nervous system disorder | Mental disorders | Dementia | Seizures
Item
history of significant neurological or psychiatric disorders including dementia or seizures,
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disseminated Intravascular Coagulation
Item
active disseminated intravascular coagulation
boolean
C0012739 (UMLS CUI [1])
Comorbidity Serious Study Subject Participation Status Impaired
Item
other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
Antidepressive Agents Peripheral sensory neuropathy | Antiepileptic Agents Peripheral sensory neuropathy
Item
use of antidepressant/antiepileptic medication (for the treatment of psn), unless commenced before informed consent form signed. the addition of these medications (for the treatment of psn) once the patient has consented is not allowed
boolean
C0003289 (UMLS CUI [1,1])
C0151313 (UMLS CUI [1,2])
C0003299 (UMLS CUI [2,1])
C0151313 (UMLS CUI [2,2])
Investigational New Drugs
Item
concurrent treatment with any other experimental drugs
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Postmenopausal state Amenorrhea Duration
Item
women of childbearing potential must be protected by effective contraceptive methods of birth control. post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0002453 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Psychological Factors Preventing Protocol Compliance | Factor Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. those conditions should be assessed with the patient before registration in the trial.
boolean
C0033898 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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