UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003497 |
|---|---|
| Receipt number | R000004236 |
| Scientific Title | Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients with breast cancer who received axillary lymphnode dissection |
| Date of disclosure of the study information | 2010/04/17 |
| Last modified on | 2010/04/15 20:15:05 |
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Basic information
Public title
Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients with breast cancer who received axillary lymphnode dissection
Acronym
Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients received axillary lymphnode dissection
Scientific Title
Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients with breast cancer who received axillary lymphnode dissection
Scientific Title:Acronym
Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients received axillary lymphnode dissection
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of postoperative peripheral venous reservation with adjuvant chemotherapy in patients who received axillary lymphnode dissection with breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of lymphedema of upper limbs
Key secondary outcomes
Incidence and grade of phlebitis.
Difficulty of peripheral venous reservation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients receive peripheral venous reservation on the non-postoperative arm with adjuvant chemotherapy, Doxorubicin 50-60mg/square meter,or Epirubicin 60-100mg/square meter followed Docetaxel 60-75mg/square meter.
The treatment is repeated every three weeks from two to four courses.
Interventions/Control_2
Patients receive alternatively peripheral venous reservation on the postoperative or the non-postoperative arm with adjuvant chemotherapy, Doxorubicin 50-60mg/square meter,or Epirubicin 60-100mg/square meter followed Docetaxel 60-75mg/square meter.
The treatment is repeated every three weeks from two to four courses.
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
1) Unilateral breast cancer
2) Patients who received axillary lymphnode dissection level I or more.
3) Sufficient organ function
4) No incidence of lymphedema of upper limbs (including doctor's clinical determination )
5) Written informed consent
6) Suitable for receiving adjuvant chemotherapy including Anthracycline followed Docetaxel for four couses.
Key exclusion criteria
1) Bilateral breast cancer.
2) Severe disease (hepatic, renal, heart or endocrine )
3) Eastern Cooperative Oncology Group performance status (PS) of 2 to 4.
4) No lymphedema of upper limbs subjectively or objectively.
5) Allergic reaction to Anthracycline or/and Docetaxel.6) Other conditions inadequate for this research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Yanagita |
Organization
Gunma Prefectural Cancer Center
Division name
Department of Breast Oncology
Zip code
Address
617-1, Takabayashi-Nishi cho, Ota-city, Japan
TEL
+81-276-38-0771
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Yanagita |
Organization
Gunma Prefectural Cancer Center
Division name
Department of Breast Oncology
Zip code
Address
617-1, Takabayashi-Nishi cho, Ota-city, Japan
TEL
+81-276-38-0771
Homepage URL
yyanagita@gunma-cc.jp
Sponsor or person
Institute
Gunma Prefectural Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama Red Cross Hospital
Isesaki Municipal Hospital
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
群馬県立がんセンター、さいたま赤十字病院、伊勢崎市民病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 15 | Day |
Last modified on
| 2010 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004236
