UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of perioperative chemotherapy with cisplatin and dose dense paclitaxel in patients with stage IB2,IIA2 orIIB uterine cervical cancer SGSG014
Title of the study (Brief title)	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	Satoshi Yamaguchi
Organization	Hyogo Cancer Center
Division name	Gynecology
Address	13-70Kitaoji,Akashi,Hyogo
TEL	078-929-1151
Email	s-yama@hp.pref.hyogo.jp

Public contact
Name of contact person	Maki Tanioka
Organization	Hyogo Cancer Center
Division name	Medical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011312