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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009643
Receipt No. R000011312
Scientific Title Phase II trial of perioperative chemotherapy with cisplatin and dose dense paclitaxel in patients with stage IB2,IIA2 orIIB uterine cervical cancer SGSG014
Date of disclosure of the study information 2012/12/27
Last modified on 2019/01/01

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Basic information
Public title Phase II trial of perioperative chemotherapy with
cisplatin and dose dense paclitaxel in patients with
stage IB2,IIA2 orIIB uterine cervical cancer SGSG014
Acronym Phase II trial of perioperative dose dense TP in patients with
stage IB2,IIA2,IIB uterine cervical cancer (SGSG014)
Scientific Title Phase II trial of perioperative chemotherapy with
cisplatin and dose dense paclitaxel in patients with
stage IB2,IIA2 orIIB uterine cervical cancer SGSG014
Scientific Title:Acronym Phase II trial of perioperative dose dense TP in patients with
stage IB2,IIA2,IIB uterine cervical cancer (SGSG014)
Region
Japan

Condition
Condition Cervical cancer patients with clinical stage IB2, IIA, IIB
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of cisplatin and dose dense paclitaxel for cervical cancer patients with clinical stage IB2, IIA, IIb
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year recurrence-free survival rate
Key secondary outcomes response rate of neoadjuvant dose dense TP, pathologic complete response rate, safety, 2-year overall survival rate, adverse events, site of recurrence

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 cisplatin with dose dense 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
70 years-old >=
Gender Female
Key inclusion criteria 1) Pathologically confirmed uterine crvical cancer
2) Clinical stage Ib2, IIa(primary tumor diameter 4 or more cm),IIb
3) Age from 20 to 70
4) ECOG PS 0-2
5) No prior treatment
6) Normal organ function
7) Written informed consent
Key exclusion criteria 1) Usage of other experimental drugs, phenytoin or flucytosine
2) History of serious drug allergy or hypersensitivity with cisplatin or paclitaxel
3) Massive ascites, ileus
4) Active infection
5) Peripheral neuropathy grade 2-4
6) Unstable angina, myocardinal infarction within 6 months or serious arrthymia
7) Interstitial pneumonia or fibrosis
8) Double cancer
9) No coexisting severe medical conditions such as uncontrollable diabetes mellitus, hypertension or bleeding
10) Pregnancy or lactation
11) Mental disease
12) Continuus usage of steroid
13) Bilateral hydronephrosis
14) Judged as inappropriate to participate this trial by investigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Yamaguchi
Organization Hyogo Cancer Center
Division name Gynecology
Zip code
Address 13-70Kitaoji,Akashi,Hyogo
TEL 078-929-1151
Email s-yama@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maki Tanioka
Organization Hyogo Cancer Center
Division name Medical Oncology
Zip code
Address 13-70Kitaoji,Akashi,Hyogo
TEL 078-929-1151
Homepage URL
Email tanioka@hp.pref.hyogo.jp

Sponsor
Institute Sankai Gynecology Study Group
Institute
Department

Funding Source
Organization Sankai Gynecology Study Group
Organization
Division
Category of Funding Organization Other
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 SGSGにおいてIRBを通過した病院

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 27 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 Completed
Date of protocol fixation
2012 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information From Aug 15th to Dec 15th 2012, the trial with the same protocol identical to SGSG014 has been conducted. Nine patients enrolled in this trial will be treated as the participants in SGSG014.

Management information
Registered date
2012 Year 12 Month 27 Day
Last modified on
2019 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011312

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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