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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001539
Receipt No. R000001862
Scientific Title Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors
Date of disclosure of the study information 2009/01/01
Last modified on 2021/04/13

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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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