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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000550
Receipt No. R000000669
Scientific Title Multicenter phase II study of docetaxel and cisplatin as primary chemotherapy in patients with stage Ic-IV epithelial ovarian cancer
Date of disclosure of the study information 2006/12/18
Last modified on 2006/12/18

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Basic information
Public title Multicenter phase II study of docetaxel and cisplatin as primary chemotherapy in patients with stage Ic-IV epithelial ovarian cancer
Acronym Phase II study of docetaxel and cisplatin in patients with epithelial ovarian cancer
Scientific Title Multicenter phase II study of docetaxel and cisplatin as primary chemotherapy in patients with stage Ic-IV epithelial ovarian cancer
Scientific Title:Acronym Phase II study of docetaxel and cisplatin in patients with epithelial ovarian cancer
Region
Japan

Condition
Condition Stage Ic-IV epithelial ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of docetaxel combined with cisplatin as primary chemotherapy in patients with stage Ic-IV epithelial ovarian cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Safety, feasibility, clinical response, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination of docetaxel and cisplatin was administered every 4 weeks. Docetaxel (70 mg/m2) was administered intravenously over 1-2 hours. Cisplatin (60 mg/m2) was administered intravenously over 2-3 hours with adequate hydration before and after. Patients were planned to receive at least 6 courses of combination treatment unless disease progression or unacceptable toxicity was observed.
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
75 years-old >
Gender Female
Key inclusion criteria 1. Histologically confirmed epithelial ovarian cancer with International Federation of Gynecology and Obstetrics stage Ic to IV
2. Not received any prior therapy including chemo- and radiotherapy, and treatment with biologic response modifier.
3. Eastern Cooperative Oncology Group performance status of 0 to 2
4. At least 20 and less than 75 years of age
5. A life expectancy of at least 3 months
6. A white blood cell count between 4000/mm3 and 12000/mm3
7. A neutrophil count >= 2000/mm3
8. A platelet count >= 100000/mm3
9. Hemoglobin >= 9.0 g/dL
10. Serum bilirubin <= 1.5 mg/dL
11. Aspartate aminotransferase and alanine aminotransferase <= 1.5 x the upper normal limit (UNL)
12. Alkaline phosphatase <= 2.5 x UNL
13. Serum creatinine <= 1.5 mg/dL
14. Creatinine clearance >= 60 mL/min
15. Written informed consent
Key exclusion criteria 1. Received only exploratory laparotomy
2. Confirmed infection
3. Fever (a body temperature >= 38 degrees Celsius)
4. Severe complication
5. Active concomitant malignancy
6. Brain metastasis
7. Interstitial pneumonia or lung fibrosis confirmed by chest X-ray or computed tomography
8. Pleural or peritoneal effusion that required treatment
9. Pericardial effusion
10. Motor paralysis, peripheral nervous system dysfunction or edema of grade 2 or more
11. History of severe drug allergy
12. Previously received long-term corticosteroid therapy
13. Pregnant or lactating women, or women who intended to become pregnant during the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nozawa
Organization School of Medicine, Keio University
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi Shinjuku Tokyo, 160-8582
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Aoki
Organization School of Medicine, Keio University
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi Shinjuku Tokyo, 160-8582
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute A group for a study of DOC/CDDP combination chemotherapy for ovarian cancer
Institute
Department

Funding Source
Organization NO
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Presented at the 44th Annual Meeting of Japan Society of Clinical Oncology (October 18th to 20th 2006)
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
2001 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2001 Year 11 Month 01 Day
Last follow-up date
2006 Year 11 Month 01 Day
Date of closure to data entry
2006 Year 12 Month 01 Day
Date trial data considered complete
2006 Year 12 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 12 Month 18 Day
Last modified on
2006 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000669

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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