UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000179 |
|---|---|
| Receipt number | R000000244 |
| Scientific Title | Phase III trial of doxorubicin / cyclophosphamide (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802) |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2014/02/21 14:21:06 |
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Basic information
Public title
Phase III trial of doxorubicin / cyclophosphamide (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)
Acronym
Phase III trial of doxorubicin / cyclophosphamide (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)
Scientific Title
Phase III trial of doxorubicin / cyclophosphamide (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)
Scientific Title:Acronym
Phase III trial of doxorubicin / cyclophosphamide (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)
Region
| Japan |
Condition
Condition
Patients with Metatatic Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
time to treatment failure
Key secondary outcomes
overall survival, progression-free survival, response rate, adverse events
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles
Interventions/Control_2
Docetaxel 60mg/m2 every 21 days for 6 cycles
Interventions/Control_3
AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles
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
I. Hormonal therapy-resistant MBC
II. ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
III. No anthracyclines for MBC and no prior taxanes
IV. At least 6 months from the completion of adjuvant chemotherapy
V. Measurable or evaluable lesions
VI. Age: 20 to 75 years
VII. PS: 0-3
VIII. WBC >= 4,000/mm3 or ANC >= 2,000/mm3, Platelet >= 100,000/mm3,
SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5mg/dL and Cr <= 1.5mg/dL
IX. normal ECG
X. Written informed consent
Key exclusion criteria
I. pregnant
II. malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
III. Active infection
IV. other cancer present within the last 5 years
V. previous stem cell transplantation
VI. brain metastasis that requires emergent treatment
VII. relapse within 6 months after completion anthracycline or during anthracycline
VIII. more than 250mg/m2 of anthracyclines
IX. hypersensitivitiy of drug
X. interstitial pneumonitis or pulmonary fibrosis
XI. positive HBs
XII. antipsychotic medication
XIII. doctor's judgement
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemitsu Takashima, MD, PhD |
Organization
National Shikoku Cancer Center
Division name
Surgery Division
Zip code
Address
13 Horinouchi, Matsuyama, Ehime 790-0007,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Katsumata ,MD |
Organization
JCOG9802 Coordinating Office
Division name
Medical Oncology Division, National Cancer Center Hospital
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
YES
Study ID_1
NCT00190489
Org. issuing International ID_1
ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/19254942
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
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
| 1998 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000244
