Unique ID issued by UMIN | UMIN000015184 |
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Receipt number | R000017658 |
Scientific Title | Phase II study of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel (dose dense TC therapy) for locally advanced cervical cancer |
Date of disclosure of the study information | 2014/09/18 |
Last modified on | 2016/09/23 14:13:29 |
Phase II study of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel (dose dense TC therapy) for locally advanced cervical cancer
SGSG016 study
Phase II study of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel (dose dense TC therapy) for locally advanced cervical cancer
SGSG016 study
Japan |
FIGO stage Ib2, IIa2, or IIb cervical cancer
Obstetrics and Gynecology |
Malignancy
NO
To determine efficacy and safety of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel.
Safety,Efficacy
Exploratory
Explanatory
Phase II
2 year recurrence free survival
objective response rate, pathological response rate, 2 year overall survival, toxicity, site of recurrence, completion rate of protocol therapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin AUC6 (Day1), Paclitaxel 80mg/m2 (Day1, 8, 15) Q21 Days 3 cycles (Neoadjuvant)
Type III hysterectomy
Carboplatin AUC6 (Day1), Paclitaxel 80mg/m2 (Day1, 8, 15) Q21 Days 3 cycles (Adjuvant)
20 | years-old | <= |
Not applicable |
Female
1. Pathologically confirmed cervical cancer.
2. FIGO stage Ib2, IIa2, or IIb.
3. ECOG performance status: 0 to 2
4. Patient with adequate organ function.
1. Prior chemotherapy nor radiation therapy for cervical cancer.
2. Simultaneous active cancer.
3. Serious coexisting illness
4. Carrier of viral hepatitis
5. Active infection
6. Interstitial pneumonia
50
1st name | |
Middle name | |
Last name | SHOJI NAGAO |
Hyogo Cancer Center
Gynecologic Oncology
13-70Kitaoji-cho, Akashi-city
078-929-1151
nagao@hp.pref.hyogo.jp
1st name | |
Middle name | |
Last name | SHOJI NAGAO |
Hyogo Cancer Center
Gynecologic Oncology
13-70Kitaoji-cho, Akashi-city
078-929-1151
http://www.sgsg.biz
nagao@hp.pref.hyogo.jp
Sankai Gynecology Study Group
Sankai Gynecology Study Group
Other
Japan
None
None
NO
兵庫県立がんセンター(兵庫県)、鳥取大学医学部附属病院(鳥取県)、四国がんセンター(愛媛県)
2014 | Year | 09 | Month | 18 | Day |
http://www.sgsg.biz
Unpublished
No longer recruiting
2014 | Year | 07 | Month | 22 | Day |
2014 | Year | 09 | Month | 18 | Day |
2016 | Year | 12 | Month | 31 | Day |
2019 | Year | 06 | Month | 30 | Day |
2014 | Year | 09 | Month | 17 | Day |
2016 | Year | 09 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017658
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