UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000322 |
|---|---|
| Receipt number | R000000415 |
| Scientific Title | Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003) |
| Date of disclosure of the study information | 2006/02/10 |
| Last modified on | 2018/03/15 11:30:18 |
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Basic information
Public title
Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer
Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC)
(OOTR N003)
Acronym
Randomized Phase II Study of
Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Operable Breast Cancer Patients
Who were not Observed Disease Progression after FEC
(OOTR N003)
Scientific Title
Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer
Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC)
(OOTR N003)
Scientific Title:Acronym
Randomized Phase II Study of
Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Operable Breast Cancer Patients
Who were not Observed Disease Progression after FEC
(OOTR N003)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Operable breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this randomized phase II study is to compare the efficacy of treatment with 4 cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) followed by 4 cycles of docetaxel and capecitabine (TX) to 4 cycles of FEC followed by 4 cycles of docetaxel alone (T) as neoadjuvant chemotherapy in female patients with operable breast cancer {T1C-3 N0 M0(>1cm) / T1-3 N1 M0}
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathologic response (pCR rate)
Key secondary outcomes
Toxicity
Clinical response
Frequency of breast conservation surgery
Frequency of axillary lymph node conservation surgery
Disease-free survival
Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel (T)
Interventions/Control_2
5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel, capecitabine (TX)
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
T1C-3 N0 M0(>1cm) / T1-3 N1 M0}
No prior treatment for breast cancer
ECOG performance status (PS) 0-1
Adequate organ funtion
signed a Patients Informed Consent Form
Key exclusion criteria
Male
History of drug hypersensitivity
Uncontrolled medical condition
Significant interstitial pneumonia or pulmonary fibrosis by CT scan or x-ray
Suspected of infection with fever
Symptomatic Varicella
Requiring treatment of pleural or pericardial effusions
Severe edema
Severe peripheral neuropathy
Requiring treatment with the steroid is a necessity beforehand
Severe psychiatric disorders
Inflammatory breast cancer
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Ohno |
Organization
The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Center)
Division name
Breast Oncology Center
Zip code
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
sohno@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Ohno |
Organization
The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Cente
Division name
Breast Oncology Center
Zip code
Address
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL
03-3520-0111
Homepage URL
sohno@nk-cc.go.jp
Sponsor or person
Institute
Organization for Oncology and Translational Research (OOTR)
Institute
Department
Personal name
Funding Source
Organization
Organization for Oncology and Translational Research (OOTR)
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2006 | Year | 02 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000415
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