ID

30761

Description

Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00890305

Lien

https://clinicaltrials.gov/show/NCT00890305

Mots-clés

Versions (1)
  1. 19/06/2018 19/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 juin 2018

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 :

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

Eligibility Metastatic Colorectal Cancer NCT00890305

Anglais

Eligibility Metastatic Colorectal Cancer NCT00890305

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient's age is 18 years or older, both genders.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with metastatic disease who are eligible for first line folfox chemotherapy. adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
Description

Neoplasm Metastasis | Eligibility First line FOLFOX Regimen | Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic

Type de données

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0392943
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1518409
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C1518409
3. ecog performance status ≤ 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
4. at least 4 weeks from prior major surgery or radiotherapy.
Description

Major surgery Previous | Prior radiation therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134
5. life expectancy >3 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
6. hematology: anc ≥ 1.5x109/l; platelets >100x109/l.
Description

Hematology | Absolute neutrophil count | Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
7. adequate renal function
Description

Renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
8. adequate hepatic functions
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
9. normal cardiac function
Description

Cardiac function

Type de données

boolean

Alias
UMLS CUI [1]
C0232164
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
Description

Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1518409
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1518409
2. patients who had received oxaliplatin within 12 months prior to diagnosis of metastatic disease.
Description

Oxaliplatin

Type de données

boolean

Alias
UMLS CUI [1]
C0069717
3. patients on concurrent anti cancer therapy other than that allowed in the study.
Description

Cancer treatment Illicit Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C2348563
4. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
Description

Steroids | Exception Routine Antiemetics | Inhaled steroids

Type de données

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0205547
UMLS CUI [2,3]
C0003297
UMLS CUI [3]
C2065041
5. presence of clinically apparent or suspected brain metastasis.
Description

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
6. patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
Description

Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0003811
7. serious active infection at the time of pre-study screening.
Description

Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
8. active or history of autoimmune disorders/conditions.
Description

Autoimmune Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0004364
9. women who are pregnant or lactating
Description

Pregnancy | Lactation

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
10. concurrent active malignancy.
Description

Cancer Other

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
11. ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
Description

Ascites | Pleural effusion | Osteoblastic bone metastases Disease Site Solitary

Type de données

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0032227
UMLS CUI [3,1]
C3854652
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1515974
UMLS CUI [3,4]
C0205171
12. other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
Description

Cancer Other | Exception Malignant Neoplasms Cured | Exception Malignant Neoplasms Treated Adequate

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C0205411
13. subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
Description

Condition Interferes with Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
14. patients with history of life threatening allergic reactions to food or drugs
Description

Allergic Reaction Life Threatening Food | Allergic Reaction Life Threatening Pharmaceutical Preparations

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0016452
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0013227
15. patients with symptomatic peripheral neuropathy> grade 1.
Description

Peripheral Neuropathy Symptomatic CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1516728
16. known positive hiv, hepatitis b surface antigen or hepatitis c antibody.
Description

HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
Retour au début de la page

Similar models

Eligibility Metastatic Colorectal Cancer NCT00890305

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient's age is 18 years or older, both genders.
boolean
C0001779 (UMLS CUI [1])
Neoplasm Metastasis | Eligibility First line FOLFOX Regimen | Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic
Item
2. patients with metastatic disease who are eligible for first line folfox chemotherapy. adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
boolean
C0027627 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0392943 (UMLS CUI [2,3])
C0677850 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1518409 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C1518409 (UMLS CUI [4,3])
ECOG performance status
Item
3. ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Major surgery Previous | Prior radiation therapy
Item
4. at least 4 weeks from prior major surgery or radiotherapy.
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
Life Expectancy
Item
5. life expectancy >3 months
boolean
C0023671 (UMLS CUI [1])
Hematology | Absolute neutrophil count | Platelet Count measurement
Item
6. hematology: anc ≥ 1.5x109/l; platelets >100x109/l.
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Renal function
Item
7. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
8. adequate hepatic functions
boolean
C0232741 (UMLS CUI [1])
Cardiac function
Item
9. normal cardiac function
boolean
C0232164 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adjuvant therapy Disease nonmetastatic | Neoadjuvant Therapy Disease nonmetastatic
Item
1. patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
boolean
C0677850 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1518409 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1518409 (UMLS CUI [2,3])
Oxaliplatin
Item
2. patients who had received oxaliplatin within 12 months prior to diagnosis of metastatic disease.
boolean
C0069717 (UMLS CUI [1])
Cancer treatment Illicit Study Protocol
Item
3. patients on concurrent anti cancer therapy other than that allowed in the study.
boolean
C0920425 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Steroids | Exception Routine Antiemetics | Inhaled steroids
Item
4. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
boolean
C0038317 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0205547 (UMLS CUI [2,2])
C0003297 (UMLS CUI [2,3])
C2065041 (UMLS CUI [3])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected
Item
5. presence of clinically apparent or suspected brain metastasis.
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia
Item
6. patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
Communicable Disease
Item
7. serious active infection at the time of pre-study screening.
boolean
C0009450 (UMLS CUI [1])
Autoimmune Diseases
Item
8. active or history of autoimmune disorders/conditions.
boolean
C0004364 (UMLS CUI [1])
Pregnancy | Lactation
Item
9. women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
Cancer Other
Item
10. concurrent active malignancy.
boolean
C1707251 (UMLS CUI [1])
Ascites | Pleural effusion | Osteoblastic bone metastases Disease Site Solitary
Item
11. ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
boolean
C0003962 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C3854652 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
Cancer Other | Exception Malignant Neoplasms Cured | Exception Malignant Neoplasms Treated Adequate
Item
12. other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0205411 (UMLS CUI [3,4])
Condition Interferes with Protocol Compliance
Item
13. subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Allergic Reaction Life Threatening Food | Allergic Reaction Life Threatening Pharmaceutical Preparations
Item
14. patients with history of life threatening allergic reactions to food or drugs
boolean
C1527304 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Peripheral Neuropathy Symptomatic CTCAE Grades
Item
15. patients with symptomatic peripheral neuropathy> grade 1.
boolean
C0031117 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
16. known positive hiv, hepatitis b surface antigen or hepatitis c antibody.
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [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