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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2015/09/30 |
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 |
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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 |
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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 |
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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 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Faculty of Medicine, Tottori University | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 36-1 Nishi-cho, Yonago, Japan | ||||||
TEL | 0859-38-6647 | ||||||
mshima12@med.tottori-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Faculty of Medicine, Tottori University | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 36-1 Nishi-cho, Yonago, Japan | ||||||
TEL | 0859-38-6647 | ||||||
Homepage URL | |||||||
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 |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 |