Unique ID issued by UMIN | UMIN000006440 |
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Receipt number | R000007643 |
Scientific Title | Phase II trial of perioperative chemotherapy with cisplatin and dose dense paclitaxel in patients with stage Ib2-IIb uterine cervical cancer (SGSG013) |
Date of disclosure of the study information | 2011/09/29 |
Last modified on | 2014/03/30 05:07:43 |
Phase II trial of perioperative chemotherapy with cisplatin and dose dense paclitaxel in patients with
stage Ib2-IIb uterine cervical cancer
(SGSG013)
Phase II trial of perioperative dose dense TP in patients with
stage Ib2-IIb uterine cervical cancer
(SGSG013)
Phase II trial of perioperative chemotherapy with cisplatin and dose dense paclitaxel in patients with
stage Ib2-IIb uterine cervical cancer
(SGSG013)
Phase II trial of perioperative dose dense TP in patients with
stage Ib2-IIb uterine cervical cancer
(SGSG013)
Japan |
Cervical cancer patients with clinical stage Ib2, IIa with tumor diameter >=4cm, IIb
Hematology and clinical oncology | Obstetrics and Gynecology |
Malignancy
NO
To investigate the efficacy and safety of cisplatin and dose dense paclitaxel for cervical cancer patients with clinical stage Ib2, IIa with tumor diameter >=4cm, IIb
Efficacy
2-year progression free survival rate
response rate of neoadjuvant dose dense TP, pathologic complete response rate, safety, 2-year overall survival rate, adverse events, site of recurrence
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
cisplatin with dose dense paclitaxel
20 | years-old | <= |
70 | years-old | >= |
Female
1) Pathologically confirmed uterine crvical cancer
2) Clinical stage Ib2, IIa(primary tumor diameter 4 or more cm),IIb
3) Age from 20 to 70
4) ECOG PS 0-2
5) No prior treatment
6) Normal organ function
7) Written informed consent
1) Usage of other experimental drugs, phenytoin or flucytosine
2) History of serious drug allergy or hypersensitivity with cisplatin or paclitaxel
3) Massive ascites, ileus
4) Active infection
5) Peripheral neuropathy grade 2-4
6) Unstable angina, myocardinal infarction within 6 months or serious arrthymia
7) Interstitial pneumonia or fibrosis
8) Double cancer
9) No coexisting severe medical conditions such as uncontrollable diabetes mellitus, hypertension or bleeding
10) Pregnancy or lactation
11) Mental disease
12) Continuus usage of steroid
13) Bilateral hydronephrosis
14) Judged as inappropriate to participate this trial by investigators
50
1st name | |
Middle name | |
Last name | Kiyoshi Fujiwara |
Hyogo Cancer Center
Gynecology
13-70Kitaoji,Akashi,Hyogo
078-929-1151
1st name | |
Middle name | |
Last name | Maki Tanioka |
Hyogo Cancer Center
Medical Oncology
tanioka@hp.pref.hyogo.jp
Sankai Gynecology Study Group
Sankai Gynecology Study Group
Other
NO
SGSGにおいてIRBを通過した病院
2011 | Year | 09 | Month | 29 | Day |
Partially published
Completed
2011 | Year | 08 | Month | 10 | Day |
2011 | Year | 09 | Month | 01 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 01 | Month | 15 | Day |
2011 | Year | 09 | Month | 29 | Day |
2014 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007643
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