ID

35358

Description

Study of Gemcitabine+Platinium Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (BEVABEL); ODM derived from: https://clinicaltrials.gov/show/NCT02363751

Link

https://clinicaltrials.gov/show/NCT02363751

Keywords

Versions (1)
  1. 3/1/19 3/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Collecting Duct Carcinoma (Kidney) NCT02363751

English

Eligibility Collecting Duct Carcinoma (Kidney) NCT02363751

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients should be aged ≥ 18years at the inclusion,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with histologically confirmed metastatic collecting duct carcinoma,
Description

Collecting Duct Carcinoma of the Kidney metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1266044
UMLS CUI [1,2]
C1522484
3. available tumor samples for centralized reading by anatomopathologist,
Description

Availability of Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
4. patients with or without nephrectomy,
Description

Nephrectomy | Nephrectomy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0027695
UMLS CUI [2,1]
C0027695
UMLS CUI [2,2]
C0332197
5. at least one measurable lesion as per recist criteria (recist v1.1),
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
6. no prior chemotherapy nor anti-angiogenic drugs (naive patients),
Description

Prior Chemotherapy Absent | Angiogenesis Inhibitors Absent | Patients Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0596087
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0919936
7. no irradiation within 4 weeks before inclusion,
Description

Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
8. absolute neutrophil counts (anc) ≥ 1.5 x 109/l,
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
9. platelets ≥ 100 x 109/l,
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
10. hemoglobin ≥ 9 g/dl,
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
11. hepatic function : ast and alt ≤ 1.5 x uln (≤ 4 x uln in case of liver metastases); total bilirubin ≤ 1.5 x uln; alkaline phosphatase < 2 x uln (≤ 4 x uln in case of bone metastases),
Description

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Serum total bilirubin measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201850
UMLS CUI [7]
C0153690
12. renal function : creatinine clearance ≥ 60 ml/min (mdrd calculation method),
Description

Renal function | Creatinine clearance measurement MDRD formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C3839656
13. absence of proteinuria at baseline defined by < 0.3 g of protein on urine sample or < 0.5 g/24h00 on urine collection,
Description

Proteinuria Absent | Protein measurement Urine Sample | Protein measurement Urine Collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0033687
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0202202
UMLS CUI [2,2]
C1610733
UMLS CUI [3,1]
C0202202
UMLS CUI [3,2]
C0200354
14. prothrombin time (tp) or partial thromboplastin time (ptt) strictly less than 50% deviation from normal limits, of international normalized ratio (inr) strictly below 2, note: the use of full-dose oral or parenteral anticoagulants as well as aspirin or clopidogrel is permitted as long as the inr or a ptt is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment. prophylactic use of anticoagulants is allowed.
Description

Prothrombin time assay | Activated Partial Thromboplastin Time measurement | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
UMLS CUI [3]
C0525032
15. ecg with normal sinus rhythm,
Description

ECG sinus rhythm normal

Data type

boolean

Alias
UMLS CUI [1]
C1960147
16. ecog performance status: 0 - 2,
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
17. estimated life expectancy ≥ 12 weeks,
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
18. patients who have received the information sheet, dated and signed the informed consent form,
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
19. patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 6 months after the last study treatment intake.
Description

Gender | Status post Menstrual period | Gender Pregnancy test negative | Childbearing Potential Contraceptive methods | Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0025329
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0700589
20. patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
21. patients affiliated to the social security system,
Description

Patients Affiliated Social security systems

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C2371809
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment,
Description

Investigational New Drugs | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
2. prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mtor inhibitor (temsirolimus or everolimus) and targeted vegf drugs such as bevacizumab and vegf trap,
Description

Systemic therapy | Chemotherapy | Angiogenesis Inhibitors | Tyrosine Kinase Inhibitors | axitinib | sunitinib | sorafenib | pazopanib | tivozanib | mTOR Inhibitor | temsirolimus | everolimus | Pharmaceutical Preparations Targeting Vascular Endothelial Growth Factors | bevacizumab | VEGF Trap

Data type

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C3665472
UMLS CUI [3]
C0596087
UMLS CUI [4]
C2757011
UMLS CUI [5]
C1700874
UMLS CUI [6]
C1176020
UMLS CUI [7]
C1516119
UMLS CUI [8]
C1831796
UMLS CUI [9]
C2827667
UMLS CUI [10]
C2746052
UMLS CUI [11]
C1707080
UMLS CUI [12]
C0541315
UMLS CUI [13,1]
C0013227
UMLS CUI [13,2]
C1521840
UMLS CUI [13,3]
C1256770
UMLS CUI [14]
C0796392
UMLS CUI [15]
C1134659
3. evidence of current central nervous system (cns) metastases or spinal cord compression. if cns metastases are suspected, patient should undergo an mri or ct-scan of the brain (with contrast, if possible) within 28 days prior to inclusion,
Description

CNS metastases | Compression of spinal cord | CNS metastases Suspected | MRI brain | CT scan brain | CT of brain with contrast

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0037926
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C0750491
UMLS CUI [4]
C0412675
UMLS CUI [5]
C0412585
UMLS CUI [6]
C1275583
4. another histological type of renal cancer
Description

Renal carcinoma Histologic type Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1378703
UMLS CUI [1,2]
C0449574
UMLS CUI [1,3]
C0205394
5. other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pt1/a bladder cancer),
Description

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma of bladder TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699885
UMLS CUI [4,3]
C3258246
6. uncontrolled hypertension (≥ 160 mm hg systolic and/or ≥ 90 mm hg diastolic) while receiving medication,
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
7. cardio-vascular disorders: congestive heart failure ≥ nyha ii, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina,
Description

Cardiovascular Diseases | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Coronary Artery Bypass Surgery | Angina Pectoris Severe | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0010055
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0002965
8. lvef value strictly less than 50%,
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
9. current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
Description

Aspirin | clopidogrel | Oral anticoagulants | Anticoagulants Parenteral | Fibrinolytic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0070166
UMLS CUI [3]
C0354604
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C1518896
UMLS CUI [5]
C0016018
10. history of clinically significant hemorrhagic or thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or history of abdominal fistula, gi perforation, intra-abdominal abscess or active gi bleeding within 6 months prior to the first study treatment; history of haemoptysis ≥ grade 2 (defined as ≥ 2.5 ml bright red blood per episode) within 1 month of study enrolment,
Description

Event Hemorrhagic | Thromboembolism | Bleeding tendency Hereditary | Predisposition Thrombosis | Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess | Gastrointestinal Hemorrhage | Hemoptysis Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0333275
UMLS CUI [2]
C0040038
UMLS CUI [3,1]
C1458140
UMLS CUI [3,2]
C0439660
UMLS CUI [4,1]
C0220898
UMLS CUI [4,2]
C0040053
UMLS CUI [5]
C1879311
UMLS CUI [6]
C0151664
UMLS CUI [7]
C0243001
UMLS CUI [8]
C0017181
UMLS CUI [9,1]
C0019079
UMLS CUI [9,2]
C0441800
11. patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment,
Description

Operative Surgical Procedures Significant | Operation on abdominal region | Thoracic Surgical Procedures | Neurosurgical Procedures | Wound Healing Lacking | Minor Surgical Procedures | Vascular Access Device Placement

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0198482
UMLS CUI [3]
C0524832
UMLS CUI [4]
C0524850
UMLS CUI [5,1]
C0043240
UMLS CUI [5,2]
C0332268
UMLS CUI [6]
C0038904
UMLS CUI [7]
C1519955
12. patients with active ulcer,
Description

Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0041582
13. patients with untreated bone fracture,
Description

Fracture Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0016658
UMLS CUI [1,2]
C0332155
14. peripheral neuropathy grade ≥ 2 (toxicity criteria-(ctcae) v4.0),
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
15. patients with active infection requiring intravenous antibiotics at the time of first study treatment,
Description

Communicable Disease Requirement Antibiotics Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C1522726
16. in the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study,
Description

Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated | Other medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0035204
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0035204
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0018799
UMLS CUI [8,2]
C0205433
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0205433
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205433
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C2348568
UMLS CUI [11,3]
C1548788
UMLS CUI [12,1]
C0008679
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C1548788
17. immunocompromised patients, including known seropositivity for human immunodeficiency virus (hiv),
Description

Immunocompromised patient | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C0019699
18. known hypersensitivity to any component of the investigational drugs or excipients,
Description

Hypersensitivity Investigational New Drug Component | Hypersensitivity Investigational New Drug Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
19. pregnant or lactating women,
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
20. person deprived of their liberty or under judicial protection (including guardianship),
Description

Prisoners | Patient Protection Judicial | Guardianship of Patient

Data type

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1545588
UMLS CUI [2,3]
C0243116
UMLS CUI [3,1]
C0680611
UMLS CUI [3,2]
C0030705
21. patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. those conditions should be discussed with the patient before registration in the trial.
Description

Abnormal mental state Preventing Comprehension Study Protocol | Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Protocol Compliance | Condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0278061
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C3850138
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0017444
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C0332196
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Similar models

Eligibility Collecting Duct Carcinoma (Kidney) NCT02363751

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients should be aged ≥ 18years at the inclusion,
boolean
C0001779 (UMLS CUI [1])
Collecting Duct Carcinoma of the Kidney metastatic
Item
2. patients with histologically confirmed metastatic collecting duct carcinoma,
boolean
C1266044 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Availability of Tumor tissue sample
Item
3. available tumor samples for centralized reading by anatomopathologist,
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Nephrectomy | Nephrectomy Absent
Item
4. patients with or without nephrectomy,
boolean
C0027695 (UMLS CUI [1])
C0027695 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
5. at least one measurable lesion as per recist criteria (recist v1.1),
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prior Chemotherapy Absent | Angiogenesis Inhibitors Absent | Patients Therapy naive
Item
6. no prior chemotherapy nor anti-angiogenic drugs (naive patients),
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0596087 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
Therapeutic radiology procedure Absent
Item
7. no irradiation within 4 weeks before inclusion,
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absolute neutrophil count
Item
8. absolute neutrophil counts (anc) ≥ 1.5 x 109/l,
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
9. platelets ≥ 100 x 109/l,
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
10. hemoglobin ≥ 9 g/dl,
boolean
C0518015 (UMLS CUI [1])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Serum total bilirubin measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone
Item
11. hepatic function : ast and alt ≤ 1.5 x uln (≤ 4 x uln in case of liver metastases); total bilirubin ≤ 1.5 x uln; alkaline phosphatase < 2 x uln (≤ 4 x uln in case of bone metastases),
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
C0153690 (UMLS CUI [7])
Renal function | Creatinine clearance measurement MDRD formula
Item
12. renal function : creatinine clearance ≥ 60 ml/min (mdrd calculation method),
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
Proteinuria Absent | Protein measurement Urine Sample | Protein measurement Urine Collection
Item
13. absence of proteinuria at baseline defined by < 0.3 g of protein on urine sample or < 0.5 g/24h00 on urine collection,
boolean
C0033687 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0202202 (UMLS CUI [2,1])
C1610733 (UMLS CUI [2,2])
C0202202 (UMLS CUI [3,1])
C0200354 (UMLS CUI [3,2])
Prothrombin time assay | Activated Partial Thromboplastin Time measurement | International Normalized Ratio
Item
14. prothrombin time (tp) or partial thromboplastin time (ptt) strictly less than 50% deviation from normal limits, of international normalized ratio (inr) strictly below 2, note: the use of full-dose oral or parenteral anticoagulants as well as aspirin or clopidogrel is permitted as long as the inr or a ptt is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment. prophylactic use of anticoagulants is allowed.
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
ECG sinus rhythm normal
Item
15. ecg with normal sinus rhythm,
boolean
C1960147 (UMLS CUI [1])
ECOG performance status
Item
16. ecog performance status: 0 - 2,
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
17. estimated life expectancy ≥ 12 weeks,
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
18. patients who have received the information sheet, dated and signed the informed consent form,
boolean
C0021430 (UMLS CUI [1])
Gender | Status post Menstrual period | Gender Pregnancy test negative | Childbearing Potential Contraceptive methods | Partner Contraceptive methods
Item
19. patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 6 months after the last study treatment intake.
boolean
C0079399 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0025329 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0682323 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Protocol Compliance
Item
20. patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
boolean
C0525058 (UMLS CUI [1])
Patients Affiliated Social security systems
Item
21. patients affiliated to the social security system,
boolean
C0030705 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C2371809 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Study Subject Participation Status
Item
1. treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment,
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Systemic therapy | Chemotherapy | Angiogenesis Inhibitors | Tyrosine Kinase Inhibitors | axitinib | sunitinib | sorafenib | pazopanib | tivozanib | mTOR Inhibitor | temsirolimus | everolimus | Pharmaceutical Preparations Targeting Vascular Endothelial Growth Factors | bevacizumab | VEGF Trap
Item
2. prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mtor inhibitor (temsirolimus or everolimus) and targeted vegf drugs such as bevacizumab and vegf trap,
boolean
C1515119 (UMLS CUI [1])
C3665472 (UMLS CUI [2])
C0596087 (UMLS CUI [3])
C2757011 (UMLS CUI [4])
C1700874 (UMLS CUI [5])
C1176020 (UMLS CUI [6])
C1516119 (UMLS CUI [7])
C1831796 (UMLS CUI [8])
C2827667 (UMLS CUI [9])
C2746052 (UMLS CUI [10])
C1707080 (UMLS CUI [11])
C0541315 (UMLS CUI [12])
C0013227 (UMLS CUI [13,1])
C1521840 (UMLS CUI [13,2])
C1256770 (UMLS CUI [13,3])
C0796392 (UMLS CUI [14])
C1134659 (UMLS CUI [15])
CNS metastases | Compression of spinal cord | CNS metastases Suspected | MRI brain | CT scan brain | CT of brain with contrast
Item
3. evidence of current central nervous system (cns) metastases or spinal cord compression. if cns metastases are suspected, patient should undergo an mri or ct-scan of the brain (with contrast, if possible) within 28 days prior to inclusion,
boolean
C0686377 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C0686377 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0412675 (UMLS CUI [4])
C0412585 (UMLS CUI [5])
C1275583 (UMLS CUI [6])
Renal carcinoma Histologic type Other
Item
4. another histological type of renal cancer
boolean
C1378703 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma of bladder TNM clinical staging
Item
5. other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pt1/a bladder cancer),
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0699885 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
6. uncontrolled hypertension (≥ 160 mm hg systolic and/or ≥ 90 mm hg diastolic) while receiving medication,
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Cardiovascular Diseases | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Coronary Artery Bypass Surgery | Angina Pectoris Severe | Angina, Unstable
Item
7. cardio-vascular disorders: congestive heart failure ≥ nyha ii, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina,
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0002962 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0002965 (UMLS CUI [6])
Left ventricular ejection fraction
Item
8. lvef value strictly less than 50%,
boolean
C0428772 (UMLS CUI [1])
Aspirin | clopidogrel | Oral anticoagulants | Anticoagulants Parenteral | Fibrinolytic Agents
Item
9. current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
boolean
C0004057 (UMLS CUI [1])
C0070166 (UMLS CUI [2])
C0354604 (UMLS CUI [3])
C0003280 (UMLS CUI [4,1])
C1518896 (UMLS CUI [4,2])
C0016018 (UMLS CUI [5])
Event Hemorrhagic | Thromboembolism | Bleeding tendency Hereditary | Predisposition Thrombosis | Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess | Gastrointestinal Hemorrhage | Hemoptysis Grade
Item
10. history of clinically significant hemorrhagic or thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or history of abdominal fistula, gi perforation, intra-abdominal abscess or active gi bleeding within 6 months prior to the first study treatment; history of haemoptysis ≥ grade 2 (defined as ≥ 2.5 ml bright red blood per episode) within 1 month of study enrolment,
boolean
C0441471 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
C0040038 (UMLS CUI [2])
C1458140 (UMLS CUI [3,1])
C0439660 (UMLS CUI [3,2])
C0220898 (UMLS CUI [4,1])
C0040053 (UMLS CUI [4,2])
C1879311 (UMLS CUI [5])
C0151664 (UMLS CUI [6])
C0243001 (UMLS CUI [7])
C0017181 (UMLS CUI [8])
C0019079 (UMLS CUI [9,1])
C0441800 (UMLS CUI [9,2])
Operative Surgical Procedures Significant | Operation on abdominal region | Thoracic Surgical Procedures | Neurosurgical Procedures | Wound Healing Lacking | Minor Surgical Procedures | Vascular Access Device Placement
Item
11. patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment,
boolean
C0543467 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0198482 (UMLS CUI [2])
C0524832 (UMLS CUI [3])
C0524850 (UMLS CUI [4])
C0043240 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C0038904 (UMLS CUI [6])
C1519955 (UMLS CUI [7])
Ulcer
Item
12. patients with active ulcer,
boolean
C0041582 (UMLS CUI [1])
Fracture Untreated
Item
13. patients with untreated bone fracture,
boolean
C0016658 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades
Item
14. peripheral neuropathy grade ≥ 2 (toxicity criteria-(ctcae) v4.0),
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Communicable Disease Requirement Antibiotics Intravenous
Item
15. patients with active infection requiring intravenous antibiotics at the time of first study treatment,
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated | Other medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate
Item
16. in the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study,
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0018799 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205433 (UMLS CUI [10,2])
C3843040 (UMLS CUI [11,1])
C2348568 (UMLS CUI [11,2])
C1548788 (UMLS CUI [11,3])
C0008679 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
Immunocompromised patient | HIV Seropositivity
Item
17. immunocompromised patients, including known seropositivity for human immunodeficiency virus (hiv),
boolean
C0085393 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Hypersensitivity Investigational New Drug Component | Hypersensitivity Investigational New Drug Excipient
Item
18. known hypersensitivity to any component of the investigational drugs or excipients,
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
19. pregnant or lactating women,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prisoners | Patient Protection Judicial | Guardianship of Patient
Item
20. person deprived of their liberty or under judicial protection (including guardianship),
boolean
C0033167 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1545588 (UMLS CUI [2,2])
C0243116 (UMLS CUI [2,3])
C0680611 (UMLS CUI [3,1])
C0030705 (UMLS CUI [3,2])
Abnormal mental state Preventing Comprehension Study Protocol | Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Protocol Compliance | Condition Study Subject Participation Status Excluded
Item
21. patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. those conditions should be discussed with the patient before registration in the trial.
boolean
C0278061 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C3850138 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0017444 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C0332196 (UMLS CUI [6,3])
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