ID

12993

Beschreibung

A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00001384

Link

https://clinicaltrials.gov/show/NCT00001384

Stichworte

Versionen (1)
  1. 10.01.16 10.01.16 -
Hochgeladen am

10. Januar 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00001384

Englisch

Eligibility Breast Cancer NCT00001384

1 Formulare  
Criteria
Beschreibung

Criteria

patients will be eligible for study either before or after receiving adjuvant radiation therapy.
Beschreibung

adjuvant radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1522673
patients with stage iii disease will be eligible to receive this regimen as neo-adjuvant chemotherapy or as adjuvant therapy if surgery was performed prior to patient referral.
Beschreibung

chemotherapy, surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0038894
patients must be previously untreated with chemotherapy.
Beschreibung

chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
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. patients with a prior history of lower stage contralateral breast cancer, treated with surgery, and/or radiation, but not chemotherapy, are eligible for this study.
Beschreibung

malignancies

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0007847
UMLS CUI [5,1]
C0006142
UMLS CUI [5,2]
C0441988
performance status (karnofsky scale) must be greater than 70; ecog 0 to 2.
Beschreibung

karnofsky, ecog

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
absolute granulocyte count greater than 1500 per microliter and platelet count greater than 100,000 per mm(3).
Beschreibung

granulocyte count, platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
liver function tests (sgot, and total bilirubin) should be less than 2x upper limits of normal. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml per min.
Beschreibung

liver function, renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
the patient must be able to give an informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.
Beschreibung

informed consent, follow up

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1522577
patients must be greater than or equal to 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients and/or their partners must be willing to practice a non-hormonal method of contraception during therapy and for 6 months following therapy.
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
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 are excluded.
Beschreibung

comorbidities, compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients must have a normal ejection fraction by muga scan and have no angina. patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease.
Beschreibung

heart function, heart diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0232164
no patients with a history of symptomatic cns disease.
Beschreibung

CNS disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
no patients with allergy to any study medication.
Beschreibung

Allergy to protocol agent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1521826
no pregnant or lactating women.
Beschreibung

pregnant or lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
patients with bleeding disorders are ineligible for study entry as are patients requiring chronic anticoagulation.
Beschreibung

bleeding disorders, anticoagulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0003280
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Ähnliche Modelle

Eligibility Breast Cancer NCT00001384

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
adjuvant radiation therapy
Item
patients will be eligible for study either before or after receiving adjuvant radiation therapy.
boolean
C1522449 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
chemotherapy, surgery
Item
patients with stage iii disease will be eligible to receive this regimen as neo-adjuvant chemotherapy or as adjuvant therapy if surgery was performed prior to patient referral.
boolean
C0392920 (UMLS CUI [1])
C0038894 (UMLS CUI [2])
chemotherapy
Item
patients must be previously untreated with chemotherapy.
boolean
C0392920 (UMLS CUI [1])
malignancies
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. patients with a prior history of lower stage contralateral breast cancer, treated with surgery, and/or radiation, but not chemotherapy, are eligible for this study.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0007847 (UMLS CUI [4])
C0006142 (UMLS CUI [5,1])
C0441988 (UMLS CUI [5,2])
karnofsky, ecog
Item
performance status (karnofsky scale) must be greater than 70; ecog 0 to 2.
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
granulocyte count, platelet count
Item
absolute granulocyte count greater than 1500 per microliter and platelet count greater than 100,000 per mm(3).
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
liver function, renal function
Item
liver function tests (sgot, and total bilirubin) should be less than 2x upper limits of normal. serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml per min.
boolean
C0201899 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
informed consent, follow up
Item
the patient must be able to give an informed consent, and to return to nci for treatment and adequate follow-up for the period the protocol requires.
boolean
C0021430 (UMLS CUI [1])
C1522577 (UMLS CUI [2])
Age
Item
patients must be greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
contraception
Item
patients and/or their partners must be willing to practice a non-hormonal method of contraception during therapy and for 6 months following therapy.
boolean
C0700589 (UMLS CUI [1])
comorbidities, compliance
Item
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 are excluded.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
heart function, heart diseases
Item
patients must have a normal ejection fraction by muga scan and have no angina. patients should not currently require therapy for cardiac arrhythmias, congestive heart failure, or coronary artery disease.
boolean
C0018799 (UMLS CUI [1])
C0232164 (UMLS CUI [2])
CNS disease
Item
no patients with a history of symptomatic cns disease.
boolean
C0007682 (UMLS CUI [1])
Allergy to protocol agent
Item
no patients with allergy to any study medication.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
pregnant or lactating
Item
no pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
bleeding disorders, anticoagulation
Item
patients with bleeding disorders are ineligible for study entry as are patients requiring chronic anticoagulation.
boolean
C0005779 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
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