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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000179
Receipt No. 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

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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
Email

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/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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