ID

12835

Description

A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00001338

Link

https://clinicaltrials.gov/show/NCT00001338

Keywords

Versions (1)
  1. 12/29/15 12/29/15 -
Uploaded on

December 29, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00001338

English

Eligibility Breast Neoplasms NCT00001338

1 forms  
Criteria
Description

Criteria

patients who have had prior radiation therapy providing there was not more than 20% of the bone marrow has been irradiated.
Description

patients who have had prior radiation therapy providing there was not more than 20% of the bone marrow has been irradiated.

Data type

boolean

Alias
UMLS CUI [1]
C1522449
patients who have received less than or equal to 360mg/m2 of adriamycin as adjuvant therapy.
Description

patients who have received less than or equal to 360mg/m2 of adriamycin as adjuvant therapy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0085752
patients must be previously untreated with chemotherapy for metastatic disease.
Description

patients must be previously untreated with chemotherapy for metastatic disease.

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.
Description

there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
performance status (karnofsky scale) must be greater than 70; ecog 0-2.
Description

performance status (karnofsky scale) must be greater than 70; ecog 0-2.

Data type

boolean

Alias
UMLS CUI [1]
C1520224
absolute granulocyte count greater than 1500 microliters and platelet count greater than 100,000/mm3.
Description

absolute granulocyte count greater than 1500 microliters and platelet count greater than 100,000/mm3.

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
liver function tests (sgot, and total bilirubin) should be less than 2x the upper limits of normal unless there is evidence of hepatic involvement with tumor. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min.
Description

liver function tests (sgot, and total bilirubin) should be less than 2x the upper limits of normal unless there is evidence of hepatic involvement with tumor. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min.

Data type

boolean

Alias
UMLS CUI [1]
C0004002
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
patients must be greater than or equal to 18 years of age.
Description

patients must be greater than or equal to 18 years of age.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the patient must be able to give informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.
Description

the patient must be able to give informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0814423
UMLS CUI [2,2]
C1522577
no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.
Description

no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease. patients who have received prior adriamycin or have any history of cardiac disease must have a lvef greater than 45 percent by muga.
Description

patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease. patients who have received prior adriamycin or have any history of cardiac disease must have a lvef greater than 45 percent by muga.

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1956346
UMLS CUI [4]
C0428772
no history of cns metastasis, or know seizure disorder.
Description

no history of cns metastasis, or know seizure disorder.

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0014544
no allergy to any study medication.
Description

no allergy to any study medication.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
no pregnant or lactating women.
Description

no pregnant or lactating women.

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
no patients requiring ongoing therapy for asthma.
Description

no patients requiring ongoing therapy for asthma.

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
no patients with bleeding disorders for study entry as are patients requiring chronic anticoagulation.
Description

no patients with bleeding disorders for study entry as are patients requiring chronic anticoagulation.

Data type

boolean

Alias
UMLS CUI [1]
C3251812
no patients with active infection or are known to be hiv positive.
Description

no patients with active infection or are known to be hiv positive.

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019682
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Similar models

Eligibility Breast Neoplasms NCT00001338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
radiation therapy
Item
patients who have had prior radiation therapy providing there was not more than 20% of the bone marrow has been irradiated.
boolean
C1522449 (UMLS CUI [1])
adjuvant therapy
Item
patients who have received less than or equal to 360mg/m2 of adriamycin as adjuvant therapy.
boolean
C0677850 (UMLS CUI [1,1])
C0085752 (UMLS CUI [1,2])
chemotherapy for metastatic disease
Item
patients must be previously untreated with chemotherapy for metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
previous malignancy
Item
there must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.
boolean
C0006826 (UMLS CUI [1])
performance status
Item
performance status (karnofsky scale) must be greater than 70; ecog 0-2.
boolean
C1520224 (UMLS CUI [1])
blood results
Item
absolute granulocyte count greater than 1500 microliters and platelet count greater than 100,000/mm3.
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
liver function tests
Item
liver function tests (sgot, and total bilirubin) should be less than 2x the upper limits of normal unless there is evidence of hepatic involvement with tumor. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min.
boolean
C0004002 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
age
Item
patients must be greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
the patient must be able to give informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.
boolean
C0021430 (UMLS CUI [1])
C0814423 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
poor medical or psychiatric risks
Item
no patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cardiac function
Item
patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease. patients who have received prior adriamycin or have any history of cardiac disease must have a lvef greater than 45 percent by muga.
boolean
C0003811 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0428772 (UMLS CUI [4])
CNS metastases
Item
no history of cns metastasis, or know seizure disorder.
boolean
C0686377 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
allergy to study medication
Item
no allergy to any study medication.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
pregnancy
Item
no pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
asthma therapy
Item
no patients requiring ongoing therapy for asthma.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
bleeding disorders
Item
no patients with bleeding disorders for study entry as are patients requiring chronic anticoagulation.
boolean
C3251812 (UMLS CUI [1])
active infection
Item
no patients with active infection or are known to be hiv positive.
boolean
C0009450 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
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