ID

18390

Beschrijving

Alternating Cycles of Carboplatin/Gemcitabine and Carboplatin/Taxol for Advanced Stage NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00259675

Link

https://clinicaltrials.gov/show/NCT00259675

Trefwoorden

Versies (1)
  1. 02-11-16 02-11-16 -
Geüploaded op

2 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00259675

Engels

Eligibility Non Small Cell Lung Cancer NCT00259675

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically/cytologically documented non small cell lung carcinoma.
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
2. stages iiib and iv disease, not a candidate for definitive treatment with surgery, radiation or radiation plus chemotherapy. (palliative radiotherapy will be allowed).
Beschrijving

TNM clinical staging | Indication Operative Surgical Procedures | Indication Therapeutic radiology procedure | Indication Therapeutic radiology procedure In addition to Chemotherapy | Palliative radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0543467
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1522449
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C1522449
UMLS CUI [4,3]
C0332287
UMLS CUI [4,4]
C0392920
UMLS CUI [5]
C0475092
3. age ≥ 18, < 75 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
5. no serious concomitant psychiatric illness.
Beschrijving

Mental disorder Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205404
6. informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
7. presence of measurable or evaluable disease on physical examination, ct scan, chest x-ray, ultrasound or mri scan.
Beschrijving

Measurable Disease | Evaluable Disease | Physical Examination | X-Ray Computed Tomography | Plain chest X-ray | Ultrasonography | Magnetic Resonance Imaging

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0039985
UMLS CUI [6]
C0041618
UMLS CUI [7]
C0024485
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1 ) previous chemotherapy for nsclc.
Beschrijving

Prior Chemotherapy Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
2) known cns metastases at time of registration.
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
3) laboratory values obtained <28 days prior to entry
Beschrijving

Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C1254595
anc <1.5 x 109 /l plt <100 x 109 /l hgb<100 g/l total bili >1.5 x unl (upper normal limit) alk po4 >3 x unl ast >3x unl cr >1.5 x unl.
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Hemoglobin | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201976
4) uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other disease which in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient.
Beschrijving

Diabetic - poor control | Cardiovascular Disease | Communicable Disease Serious | Disease At risk Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0007222
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205404
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C2348568
5) known hiv positive.
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
6) palliative radiotherapy to only area of measurable disease.
Beschrijving

Palliative radiotherapy Measurable Disease Area

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0205146
7) prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated non invasive carcinomas, or other cancer from which the patient has been disease free for at least five years.
Beschrijving

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in Situ Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0007099
UMLS CUI [4,2]
C1522326
8) pregnant or nursing women. men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, iud, abstinence, surgical sterilization etc).
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Female Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Sexual Abstinence | Female Sterilization

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0009905
UMLS CUI [7]
C1656586
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0036899
UMLS CUI [10]
C0015787
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00259675

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. histologically/cytologically documented non small cell lung carcinoma.
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging | Indication Operative Surgical Procedures | Indication Therapeutic radiology procedure | Indication Therapeutic radiology procedure In addition to Chemotherapy | Palliative radiotherapy
Item
2. stages iiib and iv disease, not a candidate for definitive treatment with surgery, radiation or radiation plus chemotherapy. (palliative radiotherapy will be allowed).
boolean
C3258246 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C3146298 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C0332287 (UMLS CUI [4,3])
C0392920 (UMLS CUI [4,4])
C0475092 (UMLS CUI [5])
Age
Item
3. age ≥ 18, < 75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 2
boolean
C1520224 (UMLS CUI [1])
Mental disorder Serious
Item
5. no serious concomitant psychiatric illness.
boolean
C0004936 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Informed Consent
Item
6. informed consent.
boolean
C0021430 (UMLS CUI [1])
Measurable Disease | Evaluable Disease | Physical Examination | X-Ray Computed Tomography | Plain chest X-ray | Ultrasonography | Magnetic Resonance Imaging
Item
7. presence of measurable or evaluable disease on physical examination, ct scan, chest x-ray, ultrasound or mri scan.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0039985 (UMLS CUI [5])
C0041618 (UMLS CUI [6])
C0024485 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
1 ) previous chemotherapy for nsclc.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
CNS metastases
Item
2) known cns metastases at time of registration.
boolean
C0686377 (UMLS CUI [1])
Laboratory Results
Item
3) laboratory values obtained <28 days prior to entry
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
anc <1.5 x 109 /l plt <100 x 109 /l hgb<100 g/l total bili >1.5 x unl (upper normal limit) alk po4 >3 x unl ast >3x unl cr >1.5 x unl.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Diabetic - poor control | Cardiovascular Disease | Communicable Disease Serious | Disease At risk Study Subject Participation Status
Item
4) uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other disease which in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient.
boolean
C0421258 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
HIV Seropositivity
Item
5) known hiv positive.
boolean
C0019699 (UMLS CUI [1])
Palliative radiotherapy Measurable Disease Area
Item
6) palliative radiotherapy to only area of measurable disease.
boolean
C0475092 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in Situ Treated
Item
7) prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated non invasive carcinomas, or other cancer from which the patient has been disease free for at least five years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0007099 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Female Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Sexual Abstinence | Female Sterilization
Item
8) pregnant or nursing women. men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, iud, abstinence, surgical sterilization etc).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0221829 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0015787 (UMLS CUI [10])
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