UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000564 |
|---|---|
| Receipt number | R000000685 |
| Scientific Title | Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix |
| Date of disclosure of the study information | 2007/01/01 |
| Last modified on | 2023/02/09 19:19:18 |
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Basic information
Public title
Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Acronym
Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Scientific Title
Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Scientific Title:Acronym
Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Region
| Japan |
Condition
Condition
nonsquamous cell carcinoma of uterine cervix
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety for combination chemotherapy consisting of docetaxel and carboplatin in patients with stage IVb recurrent nonsquamous cell carcinoma of uterine cervix
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Safety, Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with stage IVb recurrent nonsquamous cell carcinoma of uterine cervix
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.Patients having measurable lesions with definite histopathological diagnosis of stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
2.Recurrent patients can received any prior treatment including chemotherapy or radiotherapy as far as having interval more than 4 weeks. Concurrent combination radiotherapy can not be permitted.
3.Performance status: 0-2
4.Age: 20-75 years old
5.Patients without severe dysfunction of major organs
6.Patients can be alive over 3 moths after treatment
7.Patients must have signed informed consent.
Key exclusion criteria
1.Fever with over 38.0C
2.Infection or WBC>12,000/mm3
3.Severe complications
4.Neuropathy >Grade 2
5.Edema > Grade 2
6.Double cancer
7.Massive pleural effusion and ascites
8.Hypersensitivity reactions to docetaxel or carboplatin
9.Patients judged as exclusive case by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junzo |
| Middle name | |
| Last name | Kigawa |
Organization
Matsue city hospital
Division name
Department of Obstetrics and Gynecology
Zip code
690-8509
Address
32-1 Noshiro-cho, Matsue, Shimame
TEL
0852-60-8000
mshima12@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Muneaki |
| Middle name | |
| Last name | Shimada |
Organization
Tottori University
Division name
Department of Obstetrics and Gynecology
Zip code
683-8504
Address
36-1 Nishimachi, Yonago Japan
TEL
0859-38-6647
Homepage URL
mshima12@med.tottori-u.ac.jp
Sponsor or person
Institute
Sankai Gynecology Study Group
Institute
Department
Personal name
Funding Source
Organization
Sankai Gynecology Study Group
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
IRB of Tottori University Faculty of Medicine
Address
36-1 Nishi-cho, Yonago Japan
Tel
0859-33-1111
me-kenkyu@adm.tottori-u.ac.jp
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
| 2007 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.sgsg.biz/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33826028/
Number of participants that the trial has enrolled
50
Results
The response rate was 47.9% with 5 patients achieving complete response, 18 partial response, 14 stable disease, and 6 progressive disease. The disease control rate was 77.1%. With a median follow-up duration of 368 days, the median progression-free survival and overall survival were 6.1 months (95% CI 5.5-8.6) and 15.8 months (95% CI 18.2-28.3), respectively.
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This phase II study evaluated the efficacy and safety of docetaxel/carboplatin chemotherapy for treating patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix.
Participant flow
A total of 50 patients with International Federation of Gynecology and Obstetrics stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix were enrolled and administered docetaxel at a dose of 60 mg/m2, followed by carboplatin at a dose based on the area under the receiver operating characteristic curve of 6. The treatments were repeated every 21 days until disease progression or unacceptable adverse events. Except for two patients, 48 were eligible for evaluation. Another patient withdrew consent before treatment; adverse events were evaluated in 47.
Adverse events
The most frequent grade 3 and grade 4 hematological toxicity was neutropenia, with 38 patients (81%) having grade 4 and 4 (9%) having grade 3 neutropenia. The non-hematological toxicities were mainly grade 1 or 2 in severity.
Outcome measures
Docetaxel/carboplatin chemotherapy was effective, with a higher disease control rate and well-tolerated chemotherapeutic regimen for patients with stage IVB or recurrent non-squamous cell carcinoma of the uterine cervix.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2007 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Int J Clin Oncol
. 2021 Apr 7. doi: 10.1007/s10147-021-01903-1. Online ahead of print.
Management information
Registered date
| 2006 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000685
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