UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001539
Receipt number 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 2023/02/09 19:19:49

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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

Obstetrics 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 or person

Institute

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

Institute

Department

Personal name



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

Completed

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

2023 Year 02 Month 09 Day



Link to view the page

Value
https://center6.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