ID

41142

Beschreibung

Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC; ODM derived from: https://clinicaltrials.gov/show/NCT01631539

Link

https://clinicaltrials.gov/show/NCT01631539

Stichworte

Versionen (2)
  1. 30.06.20 30.06.20 -
  2. 30.06.20 30.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Liver Metastases NCT01631539

Englisch

Eligibility Liver Metastases NCT01631539

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of stage iv kras wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
Beschreibung

Adenocarcinoma of large intestine KRAS wild-type TNM clinical staging | Secondary malignant neoplasm of liver Unresectable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C4684887
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C1519810
2. primary tumour has been treated with complete surgical resection without evidence of residual tumour
Beschreibung

Primary Neoplasm Complete excision | Residual Tumor Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0015250
UMLS CUI [2,1]
C0543478
UMLS CUI [2,2]
C0332197
3. patients must have at least 1 measurable lesion (recist criteria)
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
4. performance status ecog 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. aged ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. life expectancy > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. no prior chemotherapy for metastatic disease
Beschreibung

Prior Chemotherapy Absent Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027627
8. hematologic function: wbc ≥ 3.0 x 10*9/l, platelets ≥ 100 x10*9/l
Beschreibung

Hematologic function | White Blood Cell Count procedure | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
9. adequate organ function as measured by:
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
serum creatinine £ 1.5 x upper limit of normal (uln)
Beschreibung

Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0700225
serum transaminases (ast & alt) £ 5 x uln
Beschreibung

Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
bilirubin> 1.5 times the upper limit of the normal range
Beschreibung

SERUM TOTAL BILIRUBIN ELEVATED

Datentyp

boolean

Alias
UMLS CUI [1]
C0595866
10. women of child bearing potential and fertile men are required to use effective contraception (negative βhcg for women of child-bearing age)
Beschreibung

Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430060
UMLS CUI [2,3]
C1513916
11. signed, written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
12. patients with patent main portal vein
Beschreibung

Main portal vein patent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C0175566
13. maximum liver involvement ≤60%
Beschreibung

Liver Involvement Maximum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0806909
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of cns metastases
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
2. contraindications to fu/lv, irinotecan or cetuximab
Beschreibung

Medical contraindication FU-LV Regimen | Medical contraindication irinotecan | Medical contraindication cetuximab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1880814
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0123931
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0995188
3. active bacterial, viral or fungal infection within 72 hours of study entry
Beschreibung

Bacterial Infections | Virus Diseases | Mycoses

Datentyp

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0026946
4. women who are pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. allergy to contrast media or history of severe hypersensitivity to study drugs.
Beschreibung

Contrast media allergy | Severe allergy Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0013230
6. presence of another concurrent malignancy. prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
7. any contraindication for hepatic embolization procedures:
Beschreibung

Medical contraindication Hepatic embolization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0744813
porto-systemic shunt
Beschreibung

Portosystemic shunt

Datentyp

boolean

Alias
UMLS CUI [1]
C0948900
hepatofugal blood flow
Beschreibung

Hepatofugal flow

Datentyp

boolean

Alias
UMLS CUI [1]
C4086746
severe atheromatosis
Beschreibung

Atheromatosis Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004153
UMLS CUI [1,2]
C0205082
8. contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
Beschreibung

Medical contraindication Catheterization hepatic artery | Peripheral Vascular Disease Severe Excludes Catheterization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4031927
UMLS CUI [2,1]
C0085096
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0007430
9. other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
Beschreibung

Other medical condition Study Subject Participation Status At risk | Other medical condition Excludes Chemoembolization | Other medical condition Interferes with Study Subject Participation Status | Surgical aspects Study Subject Participation Status At risk | Surgical aspects Exclude Chemoembolization | Surgical aspects Interfere with Study Subject Participation Status | Pharmacotherapy Study Subject Participation Status At risk | Pharmacotherapy Excludes Chemoembolization | Pharmacotherapy Interferes with Study Subject Participation Status | Therapeutic procedure Study Subject Participation Status At risk | Therapeutic procedure Excludes Chemoembolization | Therapeutic procedure Interferes with Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0796679
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0038895
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0038895
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0796679
UMLS CUI [6,1]
C0038895
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C0013216
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C0013216
UMLS CUI [8,2]
C0332196
UMLS CUI [8,3]
C0796679
UMLS CUI [9,1]
C0013216
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2348568
UMLS CUI [10,1]
C0087111
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C0087111
UMLS CUI [11,2]
C0332196
UMLS CUI [11,3]
C0796679
UMLS CUI [12,1]
C0087111
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C2348568
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Ähnliche Modelle

Eligibility Liver Metastases NCT01631539

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine KRAS wild-type TNM clinical staging | Secondary malignant neoplasm of liver Unresectable
Item
1. confirmed diagnosis of stage iv kras wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
boolean
C1319315 (UMLS CUI [1,1])
C4684887 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0494165 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Primary Neoplasm Complete excision | Residual Tumor Absent
Item
2. primary tumour has been treated with complete surgical resection without evidence of residual tumour
boolean
C0677930 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0543478 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
3. patients must have at least 1 measurable lesion (recist criteria)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
4. performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. aged ≥18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Absent Neoplasm Metastasis
Item
7. no prior chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Hematologic function | White Blood Cell Count procedure | Platelet Count measurement
Item
8. hematologic function: wbc ≥ 3.0 x 10*9/l, platelets ≥ 100 x10*9/l
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Organ function
Item
9. adequate organ function as measured by:
boolean
C0678852 (UMLS CUI [1])
Serum creatinine raised
Item
serum creatinine £ 1.5 x upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased
Item
serum transaminases (ast & alt) £ 5 x uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
SERUM TOTAL BILIRUBIN ELEVATED
Item
bilirubin> 1.5 times the upper limit of the normal range
boolean
C0595866 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
10. women of child bearing potential and fertile men are required to use effective contraception (negative βhcg for women of child-bearing age)
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430060 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Informed Consent
Item
11. signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Main portal vein patent
Item
12. patients with patent main portal vein
boolean
C1183135 (UMLS CUI [1,1])
C0175566 (UMLS CUI [1,2])
Liver Involvement Maximum
Item
13. maximum liver involvement ≤60%
boolean
C0023884 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
1. presence of cns metastases
boolean
C0686377 (UMLS CUI [1])
Medical contraindication FU-LV Regimen | Medical contraindication irinotecan | Medical contraindication cetuximab
Item
2. contraindications to fu/lv, irinotecan or cetuximab
boolean
C1301624 (UMLS CUI [1,1])
C1880814 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0123931 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0995188 (UMLS CUI [3,2])
Bacterial Infections | Virus Diseases | Mycoses
Item
3. active bacterial, viral or fungal infection within 72 hours of study entry
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
4. women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contrast media allergy | Severe allergy Investigational New Drugs
Item
5. allergy to contrast media or history of severe hypersensitivity to study drugs.
boolean
C0570562 (UMLS CUI [1])
C2945656 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
6. presence of another concurrent malignancy. prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Medical contraindication Hepatic embolization
Item
7. any contraindication for hepatic embolization procedures:
boolean
C1301624 (UMLS CUI [1,1])
C0744813 (UMLS CUI [1,2])
Portosystemic shunt
Item
porto-systemic shunt
boolean
C0948900 (UMLS CUI [1])
Hepatofugal flow
Item
hepatofugal blood flow
boolean
C4086746 (UMLS CUI [1])
Atheromatosis Severe
Item
severe atheromatosis
boolean
C0004153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Catheterization hepatic artery | Peripheral Vascular Disease Severe Excludes Catheterization
Item
8. contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
boolean
C1301624 (UMLS CUI [1,1])
C4031927 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0007430 (UMLS CUI [2,4])
Other medical condition Study Subject Participation Status At risk | Other medical condition Excludes Chemoembolization | Other medical condition Interferes with Study Subject Participation Status | Surgical aspects Study Subject Participation Status At risk | Surgical aspects Exclude Chemoembolization | Surgical aspects Interfere with Study Subject Participation Status | Pharmacotherapy Study Subject Participation Status At risk | Pharmacotherapy Excludes Chemoembolization | Pharmacotherapy Interferes with Study Subject Participation Status | Therapeutic procedure Study Subject Participation Status At risk | Therapeutic procedure Excludes Chemoembolization | Therapeutic procedure Interferes with Study Subject Participation Status
Item
9. other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0796679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0038895 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0038895 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0796679 (UMLS CUI [5,3])
C0038895 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0013216 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0013216 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C0796679 (UMLS CUI [8,3])
C0013216 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C0087111 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C0087111 (UMLS CUI [11,1])
C0332196 (UMLS CUI [11,2])
C0796679 (UMLS CUI [11,3])
C0087111 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C2348568 (UMLS CUI [12,3])
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