ID

30764

Beschreibung

A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01183494

Link

https://clinicaltrials.gov/show/NCT01183494

Stichworte

Versionen (1)
  1. 20/06/18 20/06/18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20 giugno 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT01183494

Englisch

Eligibility Metastatic Colorectal Cancer NCT01183494

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma
Beschreibung

Adenocarcinoma of large intestine metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C1522484
2. no prior chemotherapy for metastatic disease
Beschreibung

Absence Prior Chemotherapy Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0027627
3. age ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group (ecog) performance status ≤ 2 (5. life expectancy > 3 months
Beschreibung

ECOG performance status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
5. adequate organ function, including bone marrow (absolute neutrophil count (anc)
Beschreibung

Organ function | Bone Marrow function | Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0948762
≥l500/μl, haemoglobin ≥ 9g/dl, platelets ≥ 100,000/ μl); hepatic (total bilirubin < 1.6 mg/dl;sgot and sgpt < 2.5 x upper limit of normal for patients without liver metastases and < 5x upper limit of normal for patients with liver metastases); and renal (serum creatinine ≤ 1.5x upper limit of normal).
Beschreibung

Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7,1]
C0494165
UMLS CUI [7,2]
C0332197
UMLS CUI [8]
C0494165
UMLS CUI [9]
C0232804
UMLS CUI [10]
C0201976
6. patients who are eligible to be registered in the study, based upon the above criteria, will be genotyped for the ugt1a1*28 polymorphism and stratified into two groups based on the presence of the ugt1a1*1/*1 or ugt1a1*1/*28 genotype.
Beschreibung

UGT1A1*28 Allele Genotype determination | UGT1A1 gene allele 1 Genotype determination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825127
UMLS CUI [1,2]
C1285573
UMLS CUI [2,1]
C2360711
UMLS CUI [2,2]
C1285573
7. patients with the ugt1a1*28/*28 genotype or carriers of the other alleles (ta5 and ta8)will be excluded.
Beschreibung

UGT1A1*28 allele carrier Excluded | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3888950
UMLS CUI [1,2]
C0332196
UMLS CUI [2]
C3846158
8. for patients to be evaluable for response (a secondary end point), they must have at least one measurable lesion as defined by recist (i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral ct scan).
Beschreibung

Evaluable Patient Secondary Endpoint | Measurable Disease Quantity | Measurable Disease Dimension Quantity | Longest Diameter Technique conventional | Longest Diameter Spiral CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986511
UMLS CUI [1,2]
C4528314
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0552406
UMLS CUI [4,2]
C0449851
UMLS CUI [4,3]
C0439858
UMLS CUI [5,1]
C0552406
UMLS CUI [5,2]
C0860888
9. patients without measurable lesions can be included and will be evaluated only for toxicity.
Beschreibung

Measurable Disease Absent | Evaluation Toxicity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0600688
10. signed informed consent and local irb approval is required.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
11. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, up until 30 days after final study treatment. should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
Beschreibung

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior irinotecan or bevacizumab treatment
Beschreibung

irinotecan | bevacizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0123931
UMLS CUI [2]
C0796392
2. inflammatory bowel disease (crohn's disease, ulcerative colitis)
Beschreibung

Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
3. diarrhea greater than grade 1
Beschreibung

Diarrhea CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C1516728
4. bowel obstruction
Beschreibung

Intestinal Obstruction

Datentyp

boolean

Alias
UMLS CUI [1]
C0021843
5. documented brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
6. serious active infectious disease
Beschreibung

Communicable Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
7. active uncontrolled bleeding or fistulas
Beschreibung

Bleeding uncontrolled | Fistula Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C3842135
UMLS CUI [2,1]
C0016169
UMLS CUI [2,2]
C0205318
8. pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
9. radiotherapy or major surgery within 4 weeks
Beschreibung

Therapeutic radiology procedure | Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0679637
10. previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been disease-free for five years.
Beschreibung

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
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
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
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Ähnliche Modelle

Eligibility Metastatic Colorectal Cancer NCT01183494

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine metastatic
Item
1. histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Absence Prior Chemotherapy Neoplasm Metastasis
Item
2. no prior chemotherapy for metastatic disease
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Age
Item
3. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
4. eastern cooperative oncology group (ecog) performance status ≤ 2 (5. life expectancy > 3 months
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Organ function | Bone Marrow function | Absolute neutrophil count
Item
5. adequate organ function, including bone marrow (absolute neutrophil count (anc)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0948762 (UMLS CUI [3])
Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Renal function | Creatinine measurement, serum
Item
≥l500/μl, haemoglobin ≥ 9g/dl, platelets ≥ 100,000/ μl); hepatic (total bilirubin < 1.6 mg/dl;sgot and sgpt < 2.5 x upper limit of normal for patients without liver metastases and < 5x upper limit of normal for patients with liver metastases); and renal (serum creatinine ≤ 1.5x upper limit of normal).
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0494165 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0494165 (UMLS CUI [8])
C0232804 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
UGT1A1*28 Allele Genotype determination | UGT1A1 gene allele 1 Genotype determination
Item
6. patients who are eligible to be registered in the study, based upon the above criteria, will be genotyped for the ugt1a1*28 polymorphism and stratified into two groups based on the presence of the ugt1a1*1/*1 or ugt1a1*1/*28 genotype.
boolean
C2825127 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C2360711 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
UGT1A1*28 allele carrier Excluded | Other Coding
Item
7. patients with the ugt1a1*28/*28 genotype or carriers of the other alleles (ta5 and ta8)will be excluded.
boolean
C3888950 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Evaluable Patient Secondary Endpoint | Measurable Disease Quantity | Measurable Disease Dimension Quantity | Longest Diameter Technique conventional | Longest Diameter Spiral CT scan
Item
8. for patients to be evaluable for response (a secondary end point), they must have at least one measurable lesion as defined by recist (i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral ct scan).
boolean
C2986511 (UMLS CUI [1,1])
C4528314 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0552406 (UMLS CUI [4,1])
C0449851 (UMLS CUI [4,2])
C0439858 (UMLS CUI [4,3])
C0552406 (UMLS CUI [5,1])
C0860888 (UMLS CUI [5,2])
Measurable Disease Absent | Evaluation Toxicity
Item
9. patients without measurable lesions can be included and will be evaluated only for toxicity.
boolean
C1513041 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
Informed Consent
Item
10. signed informed consent and local irb approval is required.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
11. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, up until 30 days after final study treatment. should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
irinotecan | bevacizumab
Item
1. prior irinotecan or bevacizumab treatment
boolean
C0123931 (UMLS CUI [1])
C0796392 (UMLS CUI [2])
Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis
Item
2. inflammatory bowel disease (crohn's disease, ulcerative colitis)
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Diarrhea CTCAE Grades
Item
3. diarrhea greater than grade 1
boolean
C0011991 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Intestinal Obstruction
Item
4. bowel obstruction
boolean
C0021843 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
5. documented brain metastases
boolean
C0220650 (UMLS CUI [1])
Communicable Disease Serious
Item
6. serious active infectious disease
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Bleeding uncontrolled | Fistula Uncontrolled
Item
7. active uncontrolled bleeding or fistulas
boolean
C3842135 (UMLS CUI [1])
C0016169 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy
Item
8. pregnancy
boolean
C0032961 (UMLS CUI [1])
Therapeutic radiology procedure | Major surgery
Item
9. radiotherapy or major surgery within 4 weeks
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Disease Free of
Item
10. previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been disease-free for five years.
boolean
C0006826 (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])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
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