UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035856 |
|---|---|
| Receipt number | R000021610 |
| Scientific Title | Safety and efficacy of cisplatin plus paclitaxel in patients with uterine cervical cancer which has risk factors for recurrence |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2022/08/17 16:32:46 |
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Basic information
Public title
Safety and efficacy of cisplatin plus paclitaxel in patients with uterine cervical cancer which has risk factors for recurrence
Acronym
Safety and efficacy of cisplatin plus paclitaxel in patients with uterine cervical cancer which has risk factors for recurrence
Scientific Title
Safety and efficacy of cisplatin plus paclitaxel in patients with uterine cervical cancer which has risk factors for recurrence
Scientific Title:Acronym
Safety and efficacy of cisplatin plus paclitaxel in patients with uterine cervical cancer which has risk factors for recurrence
Region
| Japan |
Condition
Condition
Uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and tolerance of cisplatin plus paclitaxel as adjuvant chemotherapy in cervical cancer which has risk factors for recurrence
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
two years disease free survival rate
Key secondary outcomes
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
TP therapy (cicplatin, paclitaxel)
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
Postoperative patients with uterine cervical cancer stage I-II.
(1)who are diagnosed as uterine cervical cancer pathologically.
(2)who are underwent radical hysterectomy and have risk factors for recurrens written below.
1. more than 1/2 invasion to cervical stroma and lymphovascular invasion
2. more than 2/3 invasion to cervical stroma
3. Lymph node metastasis
4. invasion to parametrium
(3)no history of treatment other than surgery for uterine cervical cancer
(4)age, over 20years old and under 75 years old.
(5)Performance Status: 0-1
(6)normal function of organ (bone marrow, heart,liver, kidney)
(7)written informed consent is obtained
(8)who can start chemotherapy within six weeks from the surgery.
Key exclusion criteria
(1) who has severe infection after operation.
(2)who has severe complicarion.
(3)who has other cancer.
(4)who has interstitial pneumonia or pulmonary fibrosis.
(5)who have ascirtes or pleural infussion which need treatment.
(6)who has the administration contraindication to cisplatin or paclitaxel.
(7)who is severe allergic to drug.
(8)who is considered inappropriate to this study by attending doctor.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Sumi |
Organization
Osaka City University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku
TEL
06-6645-3862
sumi-toshi@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukuda |
Organization
Osaka City University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku
TEL
06-6645-3862
Homepage URL
takeshif@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology Osaka City Iniversity Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology Osaka City Iniversity Graduate School of Medicine
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
Osaka Metropolitan University Hospital Certified Review Board
Address
1-2-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-crb@omu.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
| 2019 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
75
Results
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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021610
