UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001571 |
|---|---|
| Receipt number | 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 10:02:54 |
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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
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
Sponsor or person
Institute
Nagoya university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001894
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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