Unique ID issued by UMIN | UMIN000032247 |
---|---|
Receipt number | R000036772 |
Scientific Title | Safety of 4-step carboplatin desensitization for patients with gynecological malignancies showing platinum hypersensitivity, a prospective multi-center study |
Date of disclosure of the study information | 2018/05/01 |
Last modified on | 2018/04/14 12:32:12 |
Safety of 4-step carboplatin desensitization for patients with gynecological malignancies showing platinum hypersensitivity, a prospective multi-center study
Safety of 4-step carboplatin desentization
Safety of 4-step carboplatin desensitization for patients with gynecological malignancies showing platinum hypersensitivity, a prospective multi-center study
Safety of 4-step carboplatin desentization
Japan |
uterine cervical cancer, uterine corpus cancer, ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
To assess the safety of the 4-step method carboplatin desensitization for patients showing platinum hypersensitivity reactions , compared with the 12-step method
Safety
Confirmatory
Pragmatic
Phase II
Relapse rate of hypersensitivity reaction
Search for risk factors for relapse of hypersensitivity reaction
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
carboplatin desensitization
20 | years-old | <= |
75 | years-old | >= |
Female
. recurrent of ovarian cancer or uterine corpus cancer or uterine cervical cancer
. PS 0-1
. hypersensitivity reactions (<CTCAE Grade 3)of carboplatin at previous therapy
. platinum free interval > 6 months
. regard to informed consent of this research
. with active infection
. with serious complications (such as poorly controlled high blood pressure and diabetes, bleeding tendency, collagen disease requiring steroid administration)
. with active double cancer
. complicated of serum sickness, Stevens-Johnson syndrome, toxic epidermal necrosis
. judged unsuitable by doctor
45
1st name | |
Middle name | |
Last name | MATSUNAGA TATSUYA |
Yokohama city university
Obstetrics & Gynecology
3-9 in Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
045-787-2800
tyamatsu@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | MATSUNAGA TATSUYA |
Yokohama city university
Obstetrics & Gynecology
3-9 in Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
045-787-2800
tyamatsu@yokohama-cu.ac.jp
Yokohama city university
Obstetrics & Gynecology
Yokohama city university
Obstetrics & Gynecology
Self funding
NO
2018 | Year | 05 | Month | 01 | Day |
Unpublished
Preinitiation
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 05 | Month | 15 | Day |
2018 | Year | 04 | Month | 14 | Day |
2018 | Year | 04 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036772
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |