UMIN-CTR Clinical Trial

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 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
Email	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
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	Osaka Metropolitan University Hospital Certified Review Board
Address	1-2-7, Asahimachi, Abeno-ku, Osaka
Tel	06-6645-3456
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021610