UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel (dose dense TC therapy) for locally advanced cervical cancer
Title of the study (Brief title)	SGSG016 study
Region	Japan

Condition
Condition	FIGO stage Ib2, IIa2, or IIb cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine efficacy and safety of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	2 year recurrence free survival
Key secondary outcomes	objective response rate, pathological response rate, 2 year overall survival, toxicity, site of recurrence, completion rate of protocol therapy

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	Carboplatin AUC6 (Day1), Paclitaxel 80mg/m2 (Day1, 8, 15) Q21 Days 3 cycles (Neoadjuvant) Type III hysterectomy Carboplatin AUC6 (Day1), Paclitaxel 80mg/m2 (Day1, 8, 15) Q21 Days 3 cycles (Adjuvant)
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	Not applicable
Gender	Female
Key inclusion criteria	1. Pathologically confirmed cervical cancer. 2. FIGO stage Ib2, IIa2, or IIb. 3. ECOG performance status: 0 to 2 4. Patient with adequate organ function.
Key exclusion criteria	1. Prior chemotherapy nor radiation therapy for cervical cancer. 2. Simultaneous active cancer. 3. Serious coexisting illness 4. Carrier of viral hepatitis 5. Active infection 6. Interstitial pneumonia
Target sample size	50

Research contact person
Name of lead principal investigator	SHOJI NAGAO
Organization	Hyogo Cancer Center
Division name	Gynecologic Oncology
Address	13-70Kitaoji-cho, Akashi-city
TEL	078-929-1151
Email	nagao@hp.pref.hyogo.jp

Public contact
Name of contact person	SHOJI NAGAO
Organization	Hyogo Cancer Center
Division name	Gynecologic Oncology
Address	13-70Kitaoji-cho, Akashi-city
TEL	078-929-1151
Homepage URL	http://www.sgsg.biz
Email	nagao@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	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	兵庫県立がんセンター（兵庫県）、鳥取大学医学部附属病院（鳥取県）、四国がんセンター（愛媛県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 18 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 22 Day
Anticipated trial start date	2014 Year 09 Month 18 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.sgsg.biz
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 17 Day
Last modified on	2016 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017658