UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000806 |
|---|---|
| Receipt number | R000000966 |
| Scientific Title | Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2009/09/23 11:35:57 |
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Basic information
Public title
Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial
Acronym
TBCRG03
Scientific Title
Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial
Scientific Title:Acronym
TBCRG03
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prevention of nail change by frozen glove
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Prevention of nail change by frozen glove
Key secondary outcomes
Safety, feasibility
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 | Device,equipment |
Interventions/Control_1
Frozen glove to prevent docetaxel-induced nail toxicities with right hand.
Docetaxel 75 mg/m2 IV Day 1Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 CyclesUse standard premedication
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Patients with early stage breast cancer (M0)
2.High risk node negative patients
3.Age >20 years and < 70 years,
4.ECOG performance status 0-1
5.No more than 12 weeks after most recent surgery
6.Sufficient organ function
7.Signed informed consent
8.No heart disease
Key exclusion criteria
1.As neoadjuvant and adjuvant therapy , treated hormone therapy and chemotherapy
2.HER2 / neu gene overexpressed or amplified
3.A history of whitlow and cold allergy
4.Bilateral breast cancer and Inflammatory breast cancer
5.Uncontrolled medical conditions
6.Hepatitis B
7.A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
8.Sever infection
9.Peripheral neuropathy
10.Pleural or pericardial effusion requiring treatment
11.Pregnant or lactating women and women of child bearing potential not using contraception.
12.Grade2-4 Severe peripheral edema.
13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
14.A history of hypersensitivity reaction to drugs formulated with Polysorbate 80
15.Severe psychiatric disorders
16.Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroji Iwata |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL
052-762-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Data Center Oncology Unit of Japan Clinical Research Support Unit (J-CRSU)
Division name
Data Center of Comprehensive Support Project for Oncology Research of Breast Cancer (CSPOR-BC)
Zip code
Address
Nishiyama-kogyo Ochanomizu building 5F, 1-2-13, Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-3254-8029
Homepage URL
http://www.csp.or.jp/
support@csp.or.jp
Sponsor or person
Institute
Tokai Breast Cancer Clinical Research Group (TBCRG)
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 01 | 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
| 2007 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 23 | Day |
Last modified on
| 2009 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000966
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