ID

28358

Beschreibung

Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project; ODM derived from: https://clinicaltrials.gov/show/NCT00661154

Link

https://clinicaltrials.gov/show/NCT00661154

Stichworte

Versionen (1)
  1. 06.01.18 06.01.18 -
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See clinicaltrials.gov

Hochgeladen am

6. Januar 2018

DOI

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Eligibility Colorectal Neoplasms NCT00661154

Englisch

Eligibility Colorectal Neoplasms NCT00661154

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed adenocarcinoma of the colon.
Beschreibung

Adenocarcinoma of colon

Datentyp

boolean

Alias
UMLS CUI [1]
C0338106
2. patients must have metastatic disease to the liver with at least one lesion that is measurable by recist criteria within 4 weeks prior to entry of study
Beschreibung

Secondary malignant neoplasm of liver | Measurable lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0494165
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
3. patients with a history of colon adenocarcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. clinicians should consider biopsy of lesions to establish diagnosis of metastatic colon adenocarcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
Beschreibung

Excision Adenocarcinoma of colon | Neoplasm Metastasis | Biopsy lesion | Adenocarcinoma of colon metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0338106
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0940828
UMLS CUI [4,1]
C0338106
UMLS CUI [4,2]
C1522484
4. patients must have ecog performance status of 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. patients must be >= 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. laboratory values <= 2 weeks prior to enrollment:
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
absolute neutrophil count (anc) >= 1.5 x 10^9/l (>= 1500/mm^3)
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets (plt) >= 100 x 10^9/l >= 100,000/mm^3)
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin (hgb) >= 9 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
serum creatinine <= 1.5 uln
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin <= 1.5 uln
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
aspartate aminotransferase (ast/sgot) and alanine aminotransferase (alt/sgpt) <= 3.0 x uln (<= 5 x uln if liver metastases present). note: ercp or percutaneous stenting may be used to normalize the liver function tests.
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | ERCP | Stenting Percutaneous | Liver Function Tests

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
UMLS CUI [4]
C0008310
UMLS CUI [5,1]
C2348535
UMLS CUI [5,2]
C0522523
UMLS CUI [6]
C0023901
negative for proteinuria based on dip stick reading or, if documentation of +1 result for protein on dip stick reading, then total urinary protein <= 500 mg and measured creatinine clearance (crcl) >= 50 ml/min from a 24-hour urine collection
Beschreibung

Protein urine absent Urine dip stick testing | Urine protein (test result) Urine dip stick testing | Creatinine clearance measurement | Urine specimen collection, 24 hours

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853155
UMLS CUI [1,2]
C0204882
UMLS CUI [2,1]
C1868687
UMLS CUI [2,2]
C0204882
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0455060
7. life expectancy >= 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
8. ability to give written informed consent according to local guidelines
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients receiving prior 5-fu for the treatment of metastatic colorectal adenocarcinoma will be excluded from enrollment. previous use of 5-fu for adjuvant treatment of resected stage ii or iii colorectal adenocarcinoma will be allowed, provided the time from last 5-fu administration to enrollment is > 3 months.
Beschreibung

Fluorouracil | Therapeutic procedure Adenocarcinoma of large intestine metastatic | Allowance Adjuvant therapy | Adenocarcinoma of large intestine Resected TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0016360
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1319315
UMLS CUI [2,3]
C1522484
UMLS CUI [3,1]
C0556660
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C1319315
UMLS CUI [4,2]
C1521996
UMLS CUI [4,3]
C3258246
2. prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. patients must have recovered from all therapy-related toxicities. the site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
Beschreibung

Therapeutic radiology procedure Full field Elapsed Time | Radiation Field Limited Elapsed Time | Toxicity Due to Therapeutic procedure | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0439724
UMLS CUI [1,3]
C2826303
UMLS CUI [2,1]
C1882536
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C2826303
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C1115804
3. prior biologic or immunotherapy <= 2 weeks prior to registration. patients must have recovered from all therapy-related toxicities
Beschreibung

Biological treatment | Immunotherapy | Toxicity Due to Therapeutic procedure | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C0021083
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C1115804
4. prior therapy with anti-vegf agents
Beschreibung

Vascular Endothelial Growth Factor Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2267120
5. patients with a history of another primary malignancy <= 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
Beschreibung

Cancer Other | Exception Basal cell carcinoma Inactive | Exception Squamous cell carcinoma of skin Inactive

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0544452
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C0544452
6. concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
7. female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. barrier contraceptives must be used throughout the trial in both sexes. women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment.
Beschreibung

Pregnancy | Breast Feeding | Adult Fertility Contraceptive methods Lacking | Barrier Contraception Required | Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0001675
UMLS CUI [3,2]
C0015895
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0332268
UMLS CUI [4,1]
C0004764
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430061
8. patients unwilling to or unable to comply with the protocol
Beschreibung

Protocol Compliance Unwilling | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Colorectal Neoplasms NCT00661154

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon
Item
1. patients must have histologically or cytologically confirmed adenocarcinoma of the colon.
boolean
C0338106 (UMLS CUI [1])
Secondary malignant neoplasm of liver | Measurable lesion Quantity
Item
2. patients must have metastatic disease to the liver with at least one lesion that is measurable by recist criteria within 4 weeks prior to entry of study
boolean
C0494165 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Excision Adenocarcinoma of colon | Neoplasm Metastasis | Biopsy lesion | Adenocarcinoma of colon metastatic
Item
3. patients with a history of colon adenocarcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. clinicians should consider biopsy of lesions to establish diagnosis of metastatic colon adenocarcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
boolean
C0728940 (UMLS CUI [1,1])
C0338106 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0940828 (UMLS CUI [3])
C0338106 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
ECOG performance status
Item
4. patients must have ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. patients must be >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Laboratory Results
Item
6. laboratory values <= 2 weeks prior to enrollment:
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >= 1.5 x 10^9/l (>= 1500/mm^3)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets (plt) >= 100 x 10^9/l >= 100,000/mm^3)
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) >= 9 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine <= 1.5 uln
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin <= 1.5 uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | ERCP | Stenting Percutaneous | Liver Function Tests
Item
aspartate aminotransferase (ast/sgot) and alanine aminotransferase (alt/sgpt) <= 3.0 x uln (<= 5 x uln if liver metastases present). note: ercp or percutaneous stenting may be used to normalize the liver function tests.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0008310 (UMLS CUI [4])
C2348535 (UMLS CUI [5,1])
C0522523 (UMLS CUI [5,2])
C0023901 (UMLS CUI [6])
Protein urine absent Urine dip stick testing | Urine protein (test result) Urine dip stick testing | Creatinine clearance measurement | Urine specimen collection, 24 hours
Item
negative for proteinuria based on dip stick reading or, if documentation of +1 result for protein on dip stick reading, then total urinary protein <= 500 mg and measured creatinine clearance (crcl) >= 50 ml/min from a 24-hour urine collection
boolean
C0853155 (UMLS CUI [1,1])
C0204882 (UMLS CUI [1,2])
C1868687 (UMLS CUI [2,1])
C0204882 (UMLS CUI [2,2])
C0373595 (UMLS CUI [3])
C0455060 (UMLS CUI [4])
Life Expectancy
Item
7. life expectancy >= 12 weeks
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
8. ability to give written informed consent according to local guidelines
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fluorouracil | Therapeutic procedure Adenocarcinoma of large intestine metastatic | Allowance Adjuvant therapy | Adenocarcinoma of large intestine Resected TNM clinical staging
Item
1. patients receiving prior 5-fu for the treatment of metastatic colorectal adenocarcinoma will be excluded from enrollment. previous use of 5-fu for adjuvant treatment of resected stage ii or iii colorectal adenocarcinoma will be allowed, provided the time from last 5-fu administration to enrollment is > 3 months.
boolean
C0016360 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1319315 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C0556660 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C1319315 (UMLS CUI [4,1])
C1521996 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
Therapeutic radiology procedure Full field Elapsed Time | Radiation Field Limited Elapsed Time | Toxicity Due to Therapeutic procedure | Patient recovered
Item
2. prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. patients must have recovered from all therapy-related toxicities. the site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
boolean
C1522449 (UMLS CUI [1,1])
C0439724 (UMLS CUI [1,2])
C2826303 (UMLS CUI [1,3])
C1882536 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2826303 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Biological treatment | Immunotherapy | Toxicity Due to Therapeutic procedure | Patient recovered
Item
3. prior biologic or immunotherapy <= 2 weeks prior to registration. patients must have recovered from all therapy-related toxicities
boolean
C1531518 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Vascular Endothelial Growth Factor Inhibitors
Item
4. prior therapy with anti-vegf agents
boolean
C2267120 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Inactive | Exception Squamous cell carcinoma of skin Inactive
Item
5. patients with a history of another primary malignancy <= 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0544452 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0544452 (UMLS CUI [3,3])
Investigational New Drugs
Item
6. concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Adult Fertility Contraceptive methods Lacking | Barrier Contraception Required | Childbearing Potential Serum pregnancy test negative
Item
7. female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. barrier contraceptives must be used throughout the trial in both sexes. women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C0015895 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
C0004764 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
8. patients unwilling to or unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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