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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001571
Receipt No. R000001894
Scientific Title Postmastectomy chemoradiation therapy(weekly paclitaxel) after adjuvant or neoadjuvant chemothrapy in breast cancer : A phase 1 trial
Date of disclosure of the study information 2008/12/15
Last modified on 2013/06/19

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Basic information
Public title Postmastectomy chemoradiation therapy(weekly paclitaxel) after adjuvant or neoadjuvant chemothrapy in breast cancer : A phase 1 trial
Acronym Phase 1 trial of postmastectomy chemoradiation
Scientific Title Postmastectomy chemoradiation therapy(weekly paclitaxel) after adjuvant or neoadjuvant chemothrapy in breast cancer : A phase 1 trial
Scientific Title:Acronym Phase 1 trial of postmastectomy chemoradiation
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To decide a maximum tolerated dose of weekly paclitaxel with concurrent radiation therapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The decision of a maximum tolerated dose of weekly paclitaxel with concurrent radiation therapy
Key secondary outcomes The decisin of a recommended dose of weekly paclitaxel with concurrent radiation therapy and confirmation of adverse reaction

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Weekly paclitaxel with concurrent radiation therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key 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




Key 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
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ando
Organization Nagoya university hospital
Division name Chemotherapeutics
Zip code
Address 65,tsurumai cho,shouwa ku,nagoya city
TEL 052-744-1902
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sachi Morita
Organization Nagoya university hospital
Division name Chemotherapeutics
Zip code
Address
TEL 052-744-1902
Homepage URL
Email

Sponsor
Institute Nagoya university hospital
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2008 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2013 Year 05 Month 30 Day
Date of closure to data entry
2013 Year 05 Month 30 Day
Date trial data considered complete
2013 Year 05 Month 30 Day
Date analysis concluded
2013 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 12 Day
Last modified on
2013 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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