ID

36399

Beschreibung

Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02300922

Link

https://clinicaltrials.gov/show/NCT02300922

Stichworte

Versionen (1)
  1. 10.05.19 10.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Mai 2019

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT02300922

Englisch

Eligibility Metastatic Colorectal Cancer NCT02300922

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. metastatic colorectal cancer and failure to standard therapies (5-fluorouracil, irinotecan, oxaliplatin, anti-vascular endothelium growth factor, anti-epidermal growth factors in patients with ras wild type tumors). a previous line with regorafenib is not required.
Beschreibung

Colorectal Carcinoma metastatic | Standard therapy failed | Fluorouracil | irinotecan | oxaliplatin | Vascular Endothelial Growth Factor Receptor Inhibitors | Anti-epidermal growth factor receptor | Neoplasms RAS Wild Type

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0016360
UMLS CUI [4]
C0123931
UMLS CUI [5]
C0069717
UMLS CUI [6]
C2267120
UMLS CUI [7]
C4055105
UMLS CUI [8,1]
C0027651
UMLS CUI [8,2]
C4331207
2. elevated cea serum level or proved cea expression in tumor tissue
Beschreibung

Elevated CEA | CEA Expression Tumor tissue sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0742014
UMLS CUI [2,1]
C0007082
UMLS CUI [2,2]
C0017262
UMLS CUI [2,3]
C0475358
3. ≥ 18 years of age,
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. given signed, written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
5. existence of at least one measurable tumor lesion by ct or mri at the time of treatment, but no single lesion ≥ 8 cm in diameter.
Beschreibung

Neoplasm Measurable lesion Quantity CT | Neoplasm Measurable lesion Quantity MRI | Lesion Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1513041
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
6. at least 4 weeks recovery period after any major surgery, radiation, or chemotherapy, and total recovery from any acute toxicities associated with these prior treatments.
Beschreibung

Recovery Time period | Status post Major surgery | Status post Therapeutic radiology procedure | Status post Chemotherapy | Toxicity Due to Prior Therapy | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C1948053
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0679637
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1522449
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1514463
UMLS CUI [6]
C1115804
7. life expectancy ≥ 3 months, karnofsky performance status of ≥ 70%
Beschreibung

Life Expectancy | Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0206065
8. adequate hematology and renal function and hepatic function
Beschreibung

Hematologic function | Renal function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
9. patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after treatment, and women of childbearing potential must have a negative serum pregnancy test to enter the study
Beschreibung

Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
exclusion criteria :
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
1. known central nervous system metastatic disease
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
2. > 25% bone marrow involvement
Beschreibung

Bone Marrow Involvement Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0439165
3. cea plasma levels >2,000 ng/ml
Beschreibung

CEA measurement Plasma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201933
UMLS CUI [1,2]
C0032105
4. patients with successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
Beschreibung

Eligibility Skin carcinoma Treated | Eligibility Carcinoma in situ of uterine cervix Treated | Eligibility Cancer Other Disease Free

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0699893
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C1707251
UMLS CUI [3,3]
C0012634
UMLS CUI [3,4]
C0332296
5. hiv positive, hepatitis b-antigen positive, or hepatitis c positive patients
Beschreibung

HIV Seropositivity | Hepatitis B antigen positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1504344
UMLS CUI [3]
C1112419
6. known autoimmune disease,
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
7. known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy, no known history of clinical significant, active chronic obstructive pulmonary disease, or other moderate to severe chronic respiratory illness present within 6 months
Beschreibung

Angina, Unstable | Myocardial Infarction | Congestive heart failure | Cardiac Arrhythmia | Exception Atrial Fibrillation Stable | Requirement Anti-Arrhythmia Agents | Chronic Obstructive Airway Disease Absent | Chronic disease of respiratory system Moderate Absent | Chronic disease of respiratory system Severe Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0003811
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0004238
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003195
UMLS CUI [7,1]
C0024117
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0264220
UMLS CUI [8,2]
C0205081
UMLS CUI [8,3]
C0332197
UMLS CUI [9,1]
C0264220
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0332197
8. infection requiring intravenous antibiotic use within 1 week before inclusion,
Beschreibung

Communicable Disease | Requirement Antibiotics Intravenous

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
UMLS CUI [2,3]
C1522726
9. corticosteroids are not allowed within 2 weeks of study entry nor during the study except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis.
Beschreibung

Adrenal Cortex Hormones | Exception Low-Dose Treatment Nausea | Exception Low-Dose Treatment Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1708745
UMLS CUI [2,3]
C0027497
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1708745
UMLS CUI [3,3]
C0003873
10. patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.
Beschreibung

Therapeutic procedure Containing Nitrosourea Compounds

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0028210
11. known hypersensitivity to murine antibodies or proteins
Beschreibung

Hypersensitivity Murine-Derived Monoclonal Antibodies | Hypersensitivity Murine protein

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2916903
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
12. immunization against tf2 for patients who has already received injection of tf2
Beschreibung

Immunization Against TF2 | TF2 Injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020971
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C2826117
UMLS CUI [2,1]
C2826117
UMLS CUI [2,2]
C1828121
13. adult patient unable to give informed consent because of intellectual impairment.
Beschreibung

Adult | Informed Consent Unable | Mental impairment

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C0683322
14. adult patient protected by the french law
Beschreibung

Adult | Protection of patient Law

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0412786
UMLS CUI [2,2]
C0220866
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Ähnliche Modelle

Eligibility Metastatic Colorectal Cancer NCT02300922

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma metastatic | Standard therapy failed | Fluorouracil | irinotecan | oxaliplatin | Vascular Endothelial Growth Factor Receptor Inhibitors | Anti-epidermal growth factor receptor | Neoplasms RAS Wild Type
Item
1. metastatic colorectal cancer and failure to standard therapies (5-fluorouracil, irinotecan, oxaliplatin, anti-vascular endothelium growth factor, anti-epidermal growth factors in patients with ras wild type tumors). a previous line with regorafenib is not required.
boolean
C0009402 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0016360 (UMLS CUI [3])
C0123931 (UMLS CUI [4])
C0069717 (UMLS CUI [5])
C2267120 (UMLS CUI [6])
C4055105 (UMLS CUI [7])
C0027651 (UMLS CUI [8,1])
C4331207 (UMLS CUI [8,2])
Elevated CEA | CEA Expression Tumor tissue sample
Item
2. elevated cea serum level or proved cea expression in tumor tissue
boolean
C0742014 (UMLS CUI [1])
C0007082 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0475358 (UMLS CUI [2,3])
Age
Item
3. ≥ 18 years of age,
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
4. given signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Neoplasm Measurable lesion Quantity CT | Neoplasm Measurable lesion Quantity MRI | Lesion Diameter
Item
5. existence of at least one measurable tumor lesion by ct or mri at the time of treatment, but no single lesion ≥ 8 cm in diameter.
boolean
C0027651 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
Recovery Time period | Status post Major surgery | Status post Therapeutic radiology procedure | Status post Chemotherapy | Toxicity Due to Prior Therapy | Patient recovered
Item
6. at least 4 weeks recovery period after any major surgery, radiation, or chemotherapy, and total recovery from any acute toxicities associated with these prior treatments.
boolean
C2004454 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0679637 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1514463 (UMLS CUI [5,3])
C1115804 (UMLS CUI [6])
Life Expectancy | Karnofsky Performance Status
Item
7. life expectancy ≥ 3 months, karnofsky performance status of ≥ 70%
boolean
C0023671 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Hematologic function | Renal function | Liver function
Item
8. adequate hematology and renal function and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
9. patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after treatment, and women of childbearing potential must have a negative serum pregnancy test to enter the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Exclusion Criteria
Item
exclusion criteria :
boolean
C0680251 (UMLS CUI [1])
CNS metastases
Item
1. known central nervous system metastatic disease
boolean
C0686377 (UMLS CUI [1])
Bone Marrow Involvement Percentage
Item
2. > 25% bone marrow involvement
boolean
C1517677 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
CEA measurement Plasma
Item
3. cea plasma levels >2,000 ng/ml
boolean
C0201933 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Eligibility Skin carcinoma Treated | Eligibility Carcinoma in situ of uterine cervix Treated | Eligibility Cancer Other Disease Free
Item
4. patients with successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
boolean
C1548635 (UMLS CUI [1,1])
C0699893 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1548635 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C0332296 (UMLS CUI [3,4])
HIV Seropositivity | Hepatitis B antigen positive | Hepatitis C positive
Item
5. hiv positive, hepatitis b-antigen positive, or hepatitis c positive patients
boolean
C0019699 (UMLS CUI [1])
C1504344 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Autoimmune Disease
Item
6. known autoimmune disease,
boolean
C0004364 (UMLS CUI [1])
Angina, Unstable | Myocardial Infarction | Congestive heart failure | Cardiac Arrhythmia | Exception Atrial Fibrillation Stable | Requirement Anti-Arrhythmia Agents | Chronic Obstructive Airway Disease Absent | Chronic disease of respiratory system Moderate Absent | Chronic disease of respiratory system Severe Absent
Item
7. known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy, no known history of clinical significant, active chronic obstructive pulmonary disease, or other moderate to severe chronic respiratory illness present within 6 months
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0004238 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0003195 (UMLS CUI [6,2])
C0024117 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0264220 (UMLS CUI [8,1])
C0205081 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
C0264220 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0332197 (UMLS CUI [9,3])
Communicable Disease | Requirement Antibiotics Intravenous
Item
8. infection requiring intravenous antibiotic use within 1 week before inclusion,
boolean
C0009450 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
Adrenal Cortex Hormones | Exception Low-Dose Treatment Nausea | Exception Low-Dose Treatment Rheumatoid Arthritis
Item
9. corticosteroids are not allowed within 2 weeks of study entry nor during the study except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis.
boolean
C0001617 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1708745 (UMLS CUI [2,2])
C0027497 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1708745 (UMLS CUI [3,2])
C0003873 (UMLS CUI [3,3])
Therapeutic procedure Containing Nitrosourea Compounds
Item
10. patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0028210 (UMLS CUI [1,3])
Hypersensitivity Murine-Derived Monoclonal Antibodies | Hypersensitivity Murine protein
Item
11. known hypersensitivity to murine antibodies or proteins
boolean
C0020517 (UMLS CUI [1,1])
C2916903 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
Immunization Against TF2 | TF2 Injection
Item
12. immunization against tf2 for patients who has already received injection of tf2
boolean
C0020971 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C2826117 (UMLS CUI [1,3])
C2826117 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Adult | Informed Consent Unable | Mental impairment
Item
13. adult patient unable to give informed consent because of intellectual impairment.
boolean
C0001675 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0683322 (UMLS CUI [3])
Adult | Protection of patient Law
Item
14. adult patient protected by the french law
boolean
C0001675 (UMLS CUI [1])
C0412786 (UMLS CUI [2,1])
C0220866 (UMLS CUI [2,2])
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