breast cancer
Conditions
Interventions
Weekly paclitaxel with concurrent radiation therapy
Sponsors
Nagoya university hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The subjects of this study were the patients who were judged as meeting all the following conditions by investigators. 1)Histological doagnosis was breast cancer. 2)Age 20-75 years old 3)Underwent complete postomastectomy 4)>=4 positive axillary nodes,1-3 positive axillary nodes with or without tumor >5cm,positive axillary nodes before or after neoadjuvant chemotherapy,T4a or N3 and so someone required postomastectomy radiation therapy by attending physician 5)Having no major organ dysfunction Neutrophils>=1500/mm3 Platelets>=100000/mm3 Hemoglobin>=9.0mg/dL Creatinine<=1.5mg/dL ALT,AST<=100IU/mL Bilirubin<=1.5mg/dL Physically normal ECG Physically normal UCG Chest Xp:lung field clear 6)Without serious complication and active second primary cancer 7)ECOG performance status 0-1 8)Having a life expectancy of >= 3 months 9)Provided written consent at the start of the study
Exclusion criteria
Exclusion criteria: This study excludes the patients who are judged as being contrary to every condition of the following conditions by investigators. 1)Severe pleural effusion,pleural effusion or ascites 2)Congestive heart failure, coronary insufficiency, acute myocardial infarction within 6 months 3)Cerebrovascular accident within 6 months 4)Poorly controlled diabetes or treated with insulin 5)Poorly controlled hypertension 6)Active infection 7)Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant after the study period 8)Psychological distress 9)Other patients judged as being inappropriate for the subjects of the study by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decision of a maximum tolerated dose of weekly paclitaxel with concurrent radiation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| The decisin of a recommended dose of weekly paclitaxel with concurrent radiation therapy and confirmation of adverse reaction | — |
Countries
Japan
Contacts
Public ContactSachi Morita
Nagoya university hospital Chemotherapeutics
Outcome results
None listed