ID

35370

Beschrijving

Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis; ODM derived from: https://clinicaltrials.gov/show/NCT02439385

Link

https://clinicaltrials.gov/show/NCT02439385

Trefwoorden

Versies (1)
  1. 03-03-19 03-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02439385

Engels

Eligibility Colorectal Cancer NCT02439385

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age : 20 years and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed adenocarcinoma of the colon or rectum
Beschrijving

Adenocarcinoma of colon | Adenocarcinoma of rectum

Datatype

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
patients with primary colon or rectal cancer and unresectable metastatic lesions.
Beschrijving

Primary malignant neoplasm of colon | Primary malignant neoplasm of rectum | Metastatic Lesion unresectable

Datatype

boolean

Alias
UMLS CUI [1]
C1304819
UMLS CUI [2]
C1306294
UMLS CUI [3,1]
C1513183
UMLS CUI [3,2]
C1519810
patients with no primary cancer related symptoms.
Beschrijving

Absence Symptoms Primary tumor Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0677930
UMLS CUI [1,4]
C0439849
ecog performance status of 0 - 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
Beschrijving

Organ function | Transaminases Hepatic Measurement | Serum total bilirubin measurement | Creatinine measurement, serum | Platelet Count measurement | Neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0002594
UMLS CUI [2,2]
C0205054
UMLS CUI [2,3]
C0242485
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0200633
asa score of < 3
Beschrijving

American Society of Anesthesiologists physical status class

Datatype

boolean

Alias
UMLS CUI [1]
C0578808
an informed consent form has been signed by the patient.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
colorectal cancer other than adenocarcinoma
Beschrijving

Colorectal Carcinoma | Exception Adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001418
the patient received adjuvant chemotherapy within the past 6 months.
Beschrijving

Chemotherapy, Adjuvant

Datatype

boolean

Alias
UMLS CUI [1]
C0085533
the patient received chemotherapy for metastatic colon cancer.
Beschrijving

Chemotherapy Secondary malignant neoplasm of colon

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0346974
the patient was planning to have curative surgery for the metastatic lesions.
Beschrijving

Curative Surgery Planned Metastatic Lesion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511562
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1513183
patients with peritoneal carcinomatosis.
Beschrijving

Carcinomatosis of peritoneal cavity

Datatype

boolean

Alias
UMLS CUI [1]
C0346990
patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
Beschrijving

Complications Primary tumor Related | Intestinal Obstruction | Hemorrhage Unresponsive to Treatment | Perforation Treatment required for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C0439849
UMLS CUI [2]
C0021843
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0549099
UMLS CUI [4,2]
C0332121
asa score of > 4
Beschrijving

American Society of Anesthesiologists physical status class

Datatype

boolean

Alias
UMLS CUI [1]
C0578808
the patient has chronic hepatitis or cirrhosis. an asymptomatic hbv or hcv carrier can participate.
Beschrijving

Hepatitis, Chronic | Liver Cirrhosis chronic | Hepatitis B carrier Asymptomatic allowed | Hepatitis C carrier Asymptomatic allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0019189
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0262505
UMLS CUI [3,2]
C0231221
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0400920
UMLS CUI [4,2]
C0231221
UMLS CUI [4,3]
C0683607
patients with an active infection, which need antibiotic therapy, during the randomization period.
Beschrijving

Communicable Disease Requirement Antibiotic therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0338237
pregnant or breastfeeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with another different malignant tumor during the past 5 years. patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
Beschrijving

Cancer Other | Exception Skin carcinoma Treated | Exception Cervical cancer Treated

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C4048328
UMLS CUI [3,3]
C1522326
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Similar models

Eligibility Colorectal Cancer NCT02439385

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age : 20 years and older
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
histologically confirmed adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Primary malignant neoplasm of colon | Primary malignant neoplasm of rectum | Metastatic Lesion unresectable
Item
patients with primary colon or rectal cancer and unresectable metastatic lesions.
boolean
C1304819 (UMLS CUI [1])
C1306294 (UMLS CUI [2])
C1513183 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
Absence Symptoms Primary tumor Related
Item
patients with no primary cancer related symptoms.
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
ECOG performance status
Item
ecog performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Transaminases Hepatic Measurement | Serum total bilirubin measurement | Creatinine measurement, serum | Platelet Count measurement | Neutrophil count
Item
appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
boolean
C0678852 (UMLS CUI [1])
C0002594 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
C1278039 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0200633 (UMLS CUI [6])
American Society of Anesthesiologists physical status class
Item
asa score of < 3
boolean
C0578808 (UMLS CUI [1])
Informed Consent
Item
an informed consent form has been signed by the patient.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Colorectal Carcinoma | Exception Adenocarcinoma
Item
colorectal cancer other than adenocarcinoma
boolean
C0009402 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
Chemotherapy, Adjuvant
Item
the patient received adjuvant chemotherapy within the past 6 months.
boolean
C0085533 (UMLS CUI [1])
Chemotherapy Secondary malignant neoplasm of colon
Item
the patient received chemotherapy for metastatic colon cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0346974 (UMLS CUI [1,2])
Curative Surgery Planned Metastatic Lesion
Item
the patient was planning to have curative surgery for the metastatic lesions.
boolean
C1511562 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1513183 (UMLS CUI [1,3])
Carcinomatosis of peritoneal cavity
Item
patients with peritoneal carcinomatosis.
boolean
C0346990 (UMLS CUI [1])
Complications Primary tumor Related | Intestinal Obstruction | Hemorrhage Unresponsive to Treatment | Perforation Treatment required for
Item
patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
boolean
C0009566 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0021843 (UMLS CUI [2])
C0019080 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0549099 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
American Society of Anesthesiologists physical status class
Item
asa score of > 4
boolean
C0578808 (UMLS CUI [1])
Hepatitis, Chronic | Liver Cirrhosis chronic | Hepatitis B carrier Asymptomatic allowed | Hepatitis C carrier Asymptomatic allowed
Item
the patient has chronic hepatitis or cirrhosis. an asymptomatic hbv or hcv carrier can participate.
boolean
C0019189 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0262505 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0400920 (UMLS CUI [4,1])
C0231221 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Communicable Disease Requirement Antibiotic therapy
Item
patients with an active infection, which need antibiotic therapy, during the randomization period.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma Treated | Exception Cervical cancer Treated
Item
patients with another different malignant tumor during the past 5 years. patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C4048328 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
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