Unique ID issued by UMIN | UMIN000001539 |
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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 |
Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors
SGSG008/ TGCU Intergroup study
Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors
SGSG008/ TGCU Intergroup study
Japan |
Stage Ib- II patients with uterine cervical nonsquamous cell carcinoma with risk factors, including pelvic lymphnode involvement and/ or parametrial extension
Obstetrics and Gynecology |
Malignancy
NO
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
Safety,Efficacy
2-year Progression free survival
Drug adverse effect, Compliance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Adjuvant chemotherapy for stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factor after radical hysterectomy
20 | years-old | <= |
75 | years-old | > |
Female
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
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
90
1st name | Muneaki |
Middle name | |
Last name | Shimada |
Faculty of Medicine, Tottori University
Department of Obstetrics and Gynecology
683-8504
36-1 Nishi-cho, Yonago, Japan
0859-38-6647
mshima12@med.tottori-u.ac.jp
1st name | Muneaki |
Middle name | |
Last name | Shimada |
Faculty of Medicine, Tottori University
Department of Obstetrics and Gynecology
683-8504
36-1 Nishi-cho, Yonago, Japan
0859-38-6647
mshima12@med.tottori-u.ac.jp
Sankai Gynecologic Study Group(SGSG), Tohoku Gynecologic Cancer Unit(TGCU)
Advanced Clinical Research Organization
Non profit foundation
IRB of Tottori University Faculty of Medicine
36-1 Nishi-cho, Yonago, Tottori, Japan
0859-33-1111
me-kenkyu@adm.tottori-u.ac.jp
NO
2009 | Year | 01 | Month | 01 | Day |
http://www.sgsg.biz/
Published
https://pubmed.ncbi.nlm.nih.gov/26825829/
37
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).
2021 | Year | 04 | Month | 13 | Day |
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.
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.
The most common grade 3/4 adverse events were hematologic toxicities, which were generally well tolerable. Nonhematologic toxicity was generally mild.
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.
Completed
2008 | Year | 03 | Month | 01 | Day |
2008 | Year | 03 | Month | 28 | Day |
2008 | Year | 04 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
Int J Gynecol Cancer. 2016 Mar;26(3):561-7. doi: 10.1097/IGC.0000000000000650.
2008 | Year | 12 | Month | 02 | Day |
2023 | Year | 02 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001862
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