UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000560 |
|---|---|
| Receipt number | R000000682 |
| Scientific Title | Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix |
| Date of disclosure of the study information | 2007/01/01 |
| Last modified on | 2023/02/09 19:18:20 |
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Basic information
Public title
Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Acronym
Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Scientific Title
Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Scientific Title:Acronym
Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II 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 neoadjuvant chemotherapy consisting of docetacel and carboplatin in patients with stage Ib2-II 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
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 Ib2 or II with diameter of over 2 cm 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
The eligibility requirements for entry into this study included a histologically confirmed diagnosis of nonsquamlous cell carcinoma of uterine cervix and no prior chemotherapytreatment. All patients were required to have a Eastern Cooperative Oncology Group performance status of <3, age 20 to 75 years, and adequate bone marrow function, liver function, and renal function defined by neutrophils > 2,000/mm3, platelets > 100,000/mm3, serum AST and ALT < 100 IU/l, serum ALP < 750 IU/l, serum total bilirubin < 1.5 mg/dl, and serum creatinine < 1.5 mg/dl. All patients were required to provide written 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 pleural effusion and ascites for which drainage are necessary.
8 previous chemotherapy by taxane compounds
Target sample size
60
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, Shimane
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 (SGSG)
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tottori University Faculty of Medicine
Address
361 Nishi-cho, Yonago, Tottori
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/27380169/
Number of participants that the trial has enrolled
61
Results
The response rate was 69 % (95 % CI, 57-82 %), with 5 patients achieving complete response, 31 partial response, 15 stable disease, and 1 progressive disease. Median follow-up duration was 1913 days with a range of 145-2632 days. Of 52 patients, 50 underwent radical hysterectomy after neoadjuvant chemotherapy. The 2-year overall survival rate was 81.8 % for stage IB2, 85.7 % for stage IIA2, and 92.6 % for stage IIB.
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted a phase II study to evaluate the efficacy of neoadjuvant chemotherapy with docetaxel and carboplatin followed by radical hysterectomy for patients with non-squamous cell carcinoma of the uterine cervix.
Participant flow
Sixty-one patients with International Federation of Gynecology and Obstetrics stage IB2, IIA2, or IIB non-squamous cell carcinoma of the uterine cervix were enrolled. The patients were administered docetaxel at a dose of 60 mg/m2, followed by carboplatin at a dose based on an area under the curve of 6. The treatments were repeated every 21 days for one to three cycles. Fifty-two patients were eligible to evaluate the efficacy of neoadjuvant chemotherapy followed by radical hysterectomy. Adverse events were evaluated in 59 patients.
Adverse events
The most frequent grade 3 and 4 hematological toxicity was neutropenia, with 43 patients experiencing grade 4 and 11 with grade 3. The nonhematological toxicities were mainly grade 1 or 2 in severity.
Outcome measures
Neoadjuvant chemotherapy with docetaxel and carboplatin followed by radical hysterectomy may be a useful strategy for patients with non-squamous cell carcinoma of uterine cervix.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2007 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Int J Clin Oncol . 2016 Dec;21(6):1128-1135. doi: 10.1007/s10147-016-1010-0. Epub 2016 Jul 5.
Management information
Registered date
| 2006 | Year | 12 | Month | 26 | 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=R000000682
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