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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035856
Receipt No. 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 2019/02/12

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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
Obsterics 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
Middle name
Last name Sumi Toshiyuki
Organization Osaka City University Graduate School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku
TEL 06-6645-3862
Email sumi-toshi@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Fukuda
Organization Osaka City University Graduate School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku
TEL 06-6645-3862
Homepage URL
Email takeshif@med.osaka-cu.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology Osaka City Iniversity Graduate School of Medicine
Institute
Department

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
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
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
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 Preinitiation
Date of protocol fixation
2015 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
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
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021610

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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