UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors
Acronym	SGSG008/ TGCU Intergroup study
Scientific Title	Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors
Scientific Title:Acronym	SGSG008/ TGCU Intergroup study
Region	Japan

Condition
Condition	Stage Ib- II patients with uterine cervical nonsquamous cell carcinoma with risk factors, including pelvic lymphnode involvement and/ or parametrial extension
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety for combination chemotherapy consisting of taxane compounds and carboplatin in patients with stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factors as adjuvant treatment after radical hysterectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year Progression free survival
Key secondary outcomes	Drug adverse effect, Compliance

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	Adjuvant chemotherapy for stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factor after radical hysterectomy
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	1.Stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factors after radical hysterectomy. Risk factors are defined as pelvic lymphnode involvement and/ or parametrial extension 2.Performance status: 0-2 3.Age: 20-74 years old 4.Patients without severe dysfunction of major organs 5.Patients can be alive over 3 months after treatment 6.Signed informed consent must be obtained
Key exclusion criteria	1.Patients with fever over 38.0 2.Patients with infection or more than WBC:12,000/mm3 3.Patients with severe complications 4.Patients with double cancer 5.Patients with massive pleural effusion, ascites and pericardiac fluid need to continuous drainage 6.Patients with neuropathy more than grade 1 7.Patients with edema more than grade 1, except for cervical adenocarcinoma 8.Patients with hypersensitivity reactions to taxane compound, carboplatin or polysorbate 80 9.Patients received neoadjuvant chemotherapy 10.Patients judged as the exclusive case by the investigator
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Muneaki Middle name Last name Shimada
Organization	Faculty of Medicine, Tottori University
Division name	Department of Obstetrics and Gynecology
Zip code	683-8504
Address	36-1 Nishi-cho, Yonago, Japan
TEL	0859-38-6647
Email	mshima12@med.tottori-u.ac.jp

Public contact
Name of contact person	1st name Muneaki Middle name Last name Shimada
Organization	Faculty of Medicine, Tottori University
Division name	Department of Obstetrics and Gynecology
Zip code	683-8504
Address	36-1 Nishi-cho, Yonago, Japan
TEL	0859-38-6647
Homepage URL
Email	mshima12@med.tottori-u.ac.jp

Sponsor
Institute	Sankai Gynecologic Study Group(SGSG), Tohoku Gynecologic Cancer Unit(TGCU)
Institute
Department

Funding Source
Organization	Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Tottori University Faculty of Medicine
Address	36-1 Nishi-cho, Yonago, Tottori, Japan
Tel	0859-33-1111
Email	me-kenkyu@adm.tottori-u.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	2009 Year 01 Month 01 Day

Related information
URL releasing protocol	http://www.sgsg.biz/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/26825829/
Number of participants that the trial has enrolled	37
Results	Twenty-two patients received PTX/CBDCA (TC) chemotherapy, and the remaining 15 patients underwent DTX/CBDCA (DC) chemotherapy. The 2-year PFS rate was 62.1% (95% confidence interval, 44.6%-75.5%). Patients receiving DC chemotherapy showed a better 2-year PFS rate compared to those with TC chemotherapy, but the difference was not statistically significant (80.0% vs 50.0%, P = 0.1400).
Results date posted	2021 Year 04 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We conducted this study to evaluate the efficacy and safety of adjuvant chemotherapy using taxane plus carboplatin (CBDCA) for high-risk stage IB-IIB patients with uterine cervical non-squamous cell carcinoma after radical hysterectomy.
Participant flow	Thirty-seven patients were eligible. Pelvic lymph node involvement and/or parametrial invasion were defined as high-risk factors. The patients were treated with 6 cycles of paclitaxel (PTX, 175 mg/m(2)) or docetaxel (DTX, 60 mg/m(2)) followed by CBDCA (area under the curve, 6) every 3 weeks. The primary end point was 2-year progression-free survival (PFS) rate, and the secondary end point was the assessment of adverse events.
Adverse events	The most common grade 3/4 adverse events were hematologic toxicities, which were generally well tolerable. Nonhematologic toxicity was generally mild.
Outcome measures	Taxane and CBDCA combination chemotherapy, especially DC chemotherapy, may be one of the useful adjuvant treatments for high-risk stage IB-IIB patients with uterine cervical non-squamous cell carcinoma after radical hysterectomy.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 03 Month 01 Day
Date of IRB	2008 Year 03 Month 28 Day
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 03 Month 01 Day
Date trial data considered complete	2013 Year 03 Month 01 Day
Date analysis concluded	2013 Year 03 Month 01 Day

Other
Other related information	Int J Gynecol Cancer. 2016 Mar;26(3):561-7. doi: 10.1097/IGC.0000000000000650.

Management information
Registered date	2008 Year 12 Month 02 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001862

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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