ID

36749

Description

Safety, Feasibility and Effect of TTFields Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02244502

Link

https://clinicaltrials.gov/show/NCT02244502

Keywords

  1. 6/6/19 6/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Ovarian Carcinoma NCT02244502

Eligibility Ovarian Carcinoma NCT02244502

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
Description

Ovarian Carcinoma | Fallopian Tube Carcinoma | Primary peritoneal carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0029925
UMLS CUI [2]
C0238122
UMLS CUI [3]
C1514428
2. recurrent ovarian cancer with any number of prior therapies
Description

Prior Therapy Quantity Ovarian cancer recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278689
3. 18 years of age and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. life expectancy of at least 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
5. measurable disease according to the revised recist criteria version 1.1. a lesion in a previously irradiated field is considered "non-measurable" and cannot be a "target lesion".
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
6. ecog score 0-1 (see appendix a)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
7. adequate bone marrow, liver and renal functions:
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
1. absolute neutrophil count ≥ 1.5 x 10 9/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count ≥ 100 x 10 9/l
Description

Platelet Count measurement

Data type

boolean

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

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
4. ast and/or alt ≤ 3 x upper limit of normal range (uln) or ≤ 5 x uln if patient has documented liver metastases
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
5. bilirubin ≤1.5 x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
6. serum creatinine ≤ 1.5 x uln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
7. coagulation status: pt and ptt within normal limits or within therapeutic limits for patients receiving anticoagulation.
Description

Blood coagulation status | Prothrombin time normal | Partial prothrombin time Normal | Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1321069
UMLS CUI [2]
C0580551
UMLS CUI [3,1]
C0853653
UMLS CUI [3,2]
C0205307
UMLS CUI [4]
C0003281
8. able to operate the novottf-100l(o) system independently or with the help of a caregiver
Description

NovoTTF-100A operate Able | Help Caregiver

Data type

boolean

Alias
UMLS CUI [1,1]
C4086635
UMLS CUI [1,2]
C3242339
UMLS CUI [1,3]
C1299581
UMLS CUI [2,1]
C1269765
UMLS CUI [2,2]
C0085537
9. no concurrent anti-tumor therapy (beyond weekly paclitaxel and novottf therapy as per protocol)
Description

Cancer treatment Concurrent Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
UMLS CUI [1,3]
C0332197
10. at least 4 weeks since major surgery
Description

Major surgery Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. meningeal carcinomatosis or known brain metastases which have not been treated, require steroid treatment, or are symptomatic.
Description

Meningeal Carcinomatosis | Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Requirement Steroid therapy | Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0149783
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C0231220
2. any other malignancy requiring anti-tumor treatment in the past three years, except resected non-melanomatous skin cancer, breast carcinoma in situ, adequately treated stage i breast cancer or in situ cervical cancer.
Description

Cancer Other Requirement Cancer treatment | Exception Skin carcinoma Resected | Exception Carcinoma in situ of female breast | Exception Breast Carcinoma TNM Breast tumor staging Treated | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1521996
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0686288
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C0474926
UMLS CUI [4,4]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
3. chemotherapy within 4 weeks prior to treatment start.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
4. radiotherapy within 4 weeks prior to treatment start.
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
5. significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:
Description

Comorbidity Affecting Prognosis | Comorbidity Affecting Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0033325
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0009429
1. history of significant cardiovascular disease unless the disease is well controlled. significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the new york heart association (nyha) class ii or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
Description

Cardiovascular Disease | Exception Cardiovascular Disease Well controlled | Second degree atrioventricular block | Complete atrioventricular block | Myocardial Ischemia | Poor hypertension control | Congestive heart failure New York Heart Association Classification | Restrict physical activity Slightly | Physical activity Resulting in Fatigue | Physical activity Resulting in Palpitations | Physical activity Resulting in Dyspnea

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007222
UMLS CUI [2,3]
C3853142
UMLS CUI [3]
C0264906
UMLS CUI [4]
C0151517
UMLS CUI [5]
C0151744
UMLS CUI [6]
C0421190
UMLS CUI [7,1]
C0018802
UMLS CUI [7,2]
C1275491
UMLS CUI [8,1]
C0515591
UMLS CUI [8,2]
C0750482
UMLS CUI [9,1]
C0026606
UMLS CUI [9,2]
C0332294
UMLS CUI [9,3]
C0015672
UMLS CUI [10,1]
C0026606
UMLS CUI [10,2]
C0332294
UMLS CUI [10,3]
C0030252
UMLS CUI [11,1]
C0026606
UMLS CUI [11,2]
C0332294
UMLS CUI [11,3]
C0013404
2. history of arrhythmia that is symptomatic or requires treatment. patients with stable atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
Description

ARRHYTHMIA SYMPTOMATIC | Cardiac Arrhythmia Treatment required for | Atrial Fibrillation controlled with medications allowed | Atrial Flutter controlled with medications allowed

Data type

boolean

Alias
UMLS CUI [1]
C0741212
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0742801
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0004239
UMLS CUI [4,2]
C0742801
UMLS CUI [4,3]
C0683607
3. active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
Description

Communicable Disease Impairing Investigational Therapy | Medical condition Serious Impairing Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0949266
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0221099
UMLS CUI [2,4]
C0949266
4. history of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent.
Description

Mental condition Impairing Comprehension Study Protocol | Mental condition Impairing Protocol Compliance | Mental condition Impairing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0021430
6. implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
Description

Wearable Electronic Devices | Artificial cardiac pacemaker | Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C4505348
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0162589
7. known history of sensitivity to taxanes or drugs containing cremophor
Description

Hypersensitivity Taxanes | Hypersensitivity Pharmaceutical Preparations Containing Cremophor

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0796419
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0056475
8. grade 2 or greater peripheral neuropathy
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
9. known allergies to medical adhesives or hydrogel
Description

Allergy to adhesive | Hypersensitivity Hydrogel

Data type

boolean

Alias
UMLS CUI [1]
C1635164
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0063083
10. pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Ovarian Carcinoma NCT02244502

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Ovarian Carcinoma | Fallopian Tube Carcinoma | Primary peritoneal carcinoma
Item
1. histologically or cytologically confirmed ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
boolean
C0029925 (UMLS CUI [1])
C0238122 (UMLS CUI [2])
C1514428 (UMLS CUI [3])
Prior Therapy Quantity Ovarian cancer recurrent
Item
2. recurrent ovarian cancer with any number of prior therapies
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278689 (UMLS CUI [1,3])
Age
Item
3. 18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Measurable Disease
Item
5. measurable disease according to the revised recist criteria version 1.1. a lesion in a previously irradiated field is considered "non-measurable" and cannot be a "target lesion".
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
6. ecog score 0-1 (see appendix a)
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
7. adequate bone marrow, liver and renal functions:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Absolute neutrophil count
Item
1. absolute neutrophil count ≥ 1.5 x 10 9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥ 100 x 10 9/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin ≥ 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
4. ast and/or alt ≤ 3 x upper limit of normal range (uln) or ≤ 5 x uln if patient has documented liver metastases
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Serum total bilirubin measurement
Item
5. bilirubin ≤1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
6. serum creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Blood coagulation status | Prothrombin time normal | Partial prothrombin time Normal | Anticoagulation Therapy
Item
7. coagulation status: pt and ptt within normal limits or within therapeutic limits for patients receiving anticoagulation.
boolean
C1321069 (UMLS CUI [1])
C0580551 (UMLS CUI [2])
C0853653 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0003281 (UMLS CUI [4])
NovoTTF-100A operate Able | Help Caregiver
Item
8. able to operate the novottf-100l(o) system independently or with the help of a caregiver
boolean
C4086635 (UMLS CUI [1,1])
C3242339 (UMLS CUI [1,2])
C1299581 (UMLS CUI [1,3])
C1269765 (UMLS CUI [2,1])
C0085537 (UMLS CUI [2,2])
Cancer treatment Concurrent Absent
Item
9. no concurrent anti-tumor therapy (beyond weekly paclitaxel and novottf therapy as per protocol)
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Major surgery Previous
Item
10. at least 4 weeks since major surgery
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Meningeal Carcinomatosis | Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Requirement Steroid therapy | Metastatic malignant neoplasm to brain Symptomatic
Item
1. meningeal carcinomatosis or known brain metastases which have not been treated, require steroid treatment, or are symptomatic.
boolean
C0220654 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0149783 (UMLS CUI [3,3])
C0220650 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Cancer Other Requirement Cancer treatment | Exception Skin carcinoma Resected | Exception Carcinoma in situ of female breast | Exception Breast Carcinoma TNM Breast tumor staging Treated | Exception Carcinoma in situ of uterine cervix
Item
2. any other malignancy requiring anti-tumor treatment in the past three years, except resected non-melanomatous skin cancer, breast carcinoma in situ, adequately treated stage i breast cancer or in situ cervical cancer.
boolean
C1707251 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1521996 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0686288 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0474926 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
Chemotherapy
Item
3. chemotherapy within 4 weeks prior to treatment start.
boolean
C0392920 (UMLS CUI [1])
Therapeutic radiology procedure
Item
4. radiotherapy within 4 weeks prior to treatment start.
boolean
C1522449 (UMLS CUI [1])
Comorbidity Affecting Prognosis | Comorbidity Affecting Combined Modality Therapy
Item
5. significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0033325 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0009429 (UMLS CUI [2,3])
Cardiovascular Disease | Exception Cardiovascular Disease Well controlled | Second degree atrioventricular block | Complete atrioventricular block | Myocardial Ischemia | Poor hypertension control | Congestive heart failure New York Heart Association Classification | Restrict physical activity Slightly | Physical activity Resulting in Fatigue | Physical activity Resulting in Palpitations | Physical activity Resulting in Dyspnea
Item
1. history of significant cardiovascular disease unless the disease is well controlled. significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the new york heart association (nyha) class ii or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
boolean
C0007222 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C3853142 (UMLS CUI [2,3])
C0264906 (UMLS CUI [3])
C0151517 (UMLS CUI [4])
C0151744 (UMLS CUI [5])
C0421190 (UMLS CUI [6])
C0018802 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
C0515591 (UMLS CUI [8,1])
C0750482 (UMLS CUI [8,2])
C0026606 (UMLS CUI [9,1])
C0332294 (UMLS CUI [9,2])
C0015672 (UMLS CUI [9,3])
C0026606 (UMLS CUI [10,1])
C0332294 (UMLS CUI [10,2])
C0030252 (UMLS CUI [10,3])
C0026606 (UMLS CUI [11,1])
C0332294 (UMLS CUI [11,2])
C0013404 (UMLS CUI [11,3])
ARRHYTHMIA SYMPTOMATIC | Cardiac Arrhythmia Treatment required for | Atrial Fibrillation controlled with medications allowed | Atrial Flutter controlled with medications allowed
Item
2. history of arrhythmia that is symptomatic or requires treatment. patients with stable atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
boolean
C0741212 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0004238 (UMLS CUI [3,1])
C0742801 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0004239 (UMLS CUI [4,1])
C0742801 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Communicable Disease Impairing Investigational Therapy | Medical condition Serious Impairing Investigational Therapy
Item
3. active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
boolean
C0009450 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0949266 (UMLS CUI [2,4])
Mental condition Impairing Comprehension Study Protocol | Mental condition Impairing Protocol Compliance | Mental condition Impairing Informed Consent
Item
4. history of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent.
boolean
C3840291 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Wearable Electronic Devices | Artificial cardiac pacemaker | Implantable defibrillator
Item
6. implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.
boolean
C4505348 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0162589 (UMLS CUI [3])
Hypersensitivity Taxanes | Hypersensitivity Pharmaceutical Preparations Containing Cremophor
Item
7. known history of sensitivity to taxanes or drugs containing cremophor
boolean
C0020517 (UMLS CUI [1,1])
C0796419 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0056475 (UMLS CUI [2,4])
Peripheral Neuropathy CTCAE Grades
Item
8. grade 2 or greater peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Allergy to adhesive | Hypersensitivity Hydrogel
Item
9. known allergies to medical adhesives or hydrogel
boolean
C1635164 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0063083 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
10. pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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