ID

36405

Description

Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02330783

Lien

https://clinicaltrials.gov/show/NCT02330783

Mots-clés

Versions (1)
  1. 11/05/2019 11/05/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

11 mai 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

Aucun commentaire

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Metastatic Renal Cell Carcinoma NCT02330783

Anglais

Eligibility Metastatic Renal Cell Carcinoma NCT02330783

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age≥18 years, ≤75 years, male or female
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
advanced renal cellcarcinoma is diagnosed histologically or pathologically
Description

Renal Cell Carcinoma Advanced

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
1st line treatment of sunitinib and 2nd line treatment of everolimus and no more systemic anti-angiogenesis targeted drug therapy
Description

First line treatment Sunitinib | Second line treatment Everolimus | Antiangiogenesis therapy Systemic

Type de données

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1176020
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0541315
UMLS CUI [3,1]
C0281318
UMLS CUI [3,2]
C0205373
have at least one measurable tumor lesion (response evaluation criteria in solid tumors)
Description

Measurable lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
eastern cooperative oncology group（ecog) performance scale is 0 or 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
the expected life span is ≥12 weeks
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
no contraindications for chemotherapy, with enough liver function and renal function and normal ecg recording peripheral hemogram: neutrophil≥1.5×109/l, plt≥100×109/l, hgb≥90g/l renal function: serum creatinine≤1.5 folds the upper limit of normal (uln) for patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 uln, for patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 uln
Description

Medical contraindication Absent Chemotherapy | Liver function | Renal function | Hematologic function | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Liver Dysfunction Without Neoplasm Metastasis | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction metastatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0392920
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0221130
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0518015
UMLS CUI [8]
C0201976
UMLS CUI [9,1]
C0086565
UMLS CUI [9,2]
C0332288
UMLS CUI [9,3]
C0027627
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0201899
UMLS CUI [12,1]
C0086565
UMLS CUI [12,2]
C1522484
the patients participate voluntarily and have signed the informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
Description

Communicable Disease Severe Poorly controlled | Infection pyogenic | Chronic infectious disease | Non-healed wound Persistent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C3853134
UMLS CUI [2]
C0858906
UMLS CUI [3]
C0151317
UMLS CUI [4,1]
C0750433
UMLS CUI [4,2]
C0205322
past history of serious heart diseases, including: cardiac function classification ≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
Description

Heart Disease Serious | Cardiac function New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0003195
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0304516
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012265
UMLS CUI [8]
C1868885
patients with a history of hiv infection or active phase of chronic hepatitis b/c
Description

HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
negative imaging examination result 4 weeks prior to enrollment)
Description

Imaging Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1513916
epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
Description

Epilepsy Requirement Pharmacotherapy | Steroids | Antiepileptic Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2]
C0038317
UMLS CUI [3]
C0003299
a history of allogeneic organ transplantation
Description

Organ Transplantation Allogeneic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C1515895
patients with evidence of hemorrhagic constitution or a past history of hemorrhage
Description

Patient constitution Hemorrhagic | Hemorrhage In the past

Type de données

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C0333275
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C1444637
patients currently receiving renal dialysis
Description

Dialysis renal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0022646
past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
Description

Cancer Other | Exception Neoplasm Cured

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C1880198
patients participating in other clinical trials simultaneously
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
other conditions unsatisfying the inclusion criteria in the investigator's opinions
Description

Condition Inconsistent Inclusion criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C1512693
Retour au début de la page

Similar models

Eligibility Metastatic Renal Cell Carcinoma NCT02330783

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age≥18 years, ≤75 years, male or female
boolean
C0001779 (UMLS CUI [1])
Renal Cell Carcinoma Advanced
Item
advanced renal cellcarcinoma is diagnosed histologically or pathologically
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
First line treatment Sunitinib | Second line treatment Everolimus | Antiangiogenesis therapy Systemic
Item
1st line treatment of sunitinib and 2nd line treatment of everolimus and no more systemic anti-angiogenesis targeted drug therapy
boolean
C1708063 (UMLS CUI [1,1])
C1176020 (UMLS CUI [1,2])
C1710038 (UMLS CUI [2,1])
C0541315 (UMLS CUI [2,2])
C0281318 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Measurable lesion Quantity
Item
have at least one measurable tumor lesion (response evaluation criteria in solid tumors)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group（ecog) performance scale is 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
the expected life span is ≥12 weeks
boolean
C0023671 (UMLS CUI [1])
Medical contraindication Absent Chemotherapy | Liver function | Renal function | Hematologic function | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Liver Dysfunction Without Neoplasm Metastasis | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Dysfunction metastatic
Item
no contraindications for chemotherapy, with enough liver function and renal function and normal ecg recording peripheral hemogram: neutrophil≥1.5×109/l, plt≥100×109/l, hgb≥90g/l renal function: serum creatinine≤1.5 folds the upper limit of normal (uln) for patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 uln, for patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 uln
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0221130 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0086565 (UMLS CUI [9,1])
C0332288 (UMLS CUI [9,2])
C0027627 (UMLS CUI [9,3])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
C0086565 (UMLS CUI [12,1])
C1522484 (UMLS CUI [12,2])
Informed Consent
Item
the patients participate voluntarily and have signed the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Communicable Disease Severe Poorly controlled | Infection pyogenic | Chronic infectious disease | Non-healed wound Persistent
Item
patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
C0858906 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0750433 (UMLS CUI [4,1])
C0205322 (UMLS CUI [4,2])
Heart Disease Serious | Cardiac function New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension
Item
past history of serious heart diseases, including: cardiac function classification ≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0003195 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0304516 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0012265 (UMLS CUI [7,2])
C1868885 (UMLS CUI [8])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
patients with a history of hiv infection or active phase of chronic hepatitis b/c
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Imaging Negative
Item
negative imaging examination result 4 weeks prior to enrollment)
boolean
C0011923 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Epilepsy Requirement Pharmacotherapy | Steroids | Antiepileptic Agents
Item
epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
Organ Transplantation Allogeneic
Item
a history of allogeneic organ transplantation
boolean
C0029216 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
Patient constitution Hemorrhagic | Hemorrhage In the past
Item
patients with evidence of hemorrhagic constitution or a past history of hemorrhage
boolean
C0683521 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
Dialysis renal
Item
patients currently receiving renal dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
Cancer Other | Exception Neoplasm Cured
Item
past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
Study Subject Participation Status
Item
patients participating in other clinical trials simultaneously
boolean
C2348568 (UMLS CUI [1])
Condition Inconsistent Inclusion criteria
Item
other conditions unsatisfying the inclusion criteria in the investigator's opinions
boolean
C0348080 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial