UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000550 |
|---|---|
| Receipt number | 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 19:46:31 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
A group for a study of DOC/CDDP combination chemotherapy for ovarian cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000669
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