Unique ID issued by UMIN | UMIN000001976 |
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Receipt number | R000002411 |
Scientific Title | The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin |
Date of disclosure of the study information | 2009/05/18 |
Last modified on | 2014/05/02 12:14:15 |
The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin
Doxil trial
The evaluation of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin
Doxil trial
Japan |
Recurrent/ Relapsed Müllerian carcinoma
Obstetrics and Gynecology |
Malignancy
NO
To evaluate the significance of supportive care for hand-foot syndrome and stomatitis in patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin (50mg/m2 q4eeks).
Safety,Efficacy
The incidence of more than grade2 hand-foot syndrome
The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to hand-foot syndrome
The incidence of more than grade2 stomatitis
The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to stomatitis
The incidence of adverse event except for hand-foot syndrome and stomatitis
The proportion of patients requiring dose reduction, dose delay, and the discontinuation due to adverse event except for hand-foot syndrome and stomatitis
Dose intensity of pegylated liposomal doxorubicin
Response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine | Behavior,custom | Maneuver |
Local Cooling
Pridoxine treatment
Dexamethasone treatment
Education for patients
20 | years-old | <= |
Not applicable |
Female
1. Patients with recurrent/ relapsed Müllerian carcinoma received chemotherapy of pegylated liposomal doxorubicin. The period from final chemotherapy should not be over 12 months. All patients should not have measurable lesions with the RECIST criteria. If the diagnosis of recurrence or relapse with only escalation of serum CA125, the diagnosis should be based on the definition of CA125 progression (GCIG criteria).
2. Performance status: 0-2
3. Age: More than 20 years old
4. Patients without severe dysfunction of major organs
5. Patients can be alive over 4 months after treatment
6. Patients must have signed informed consent
1. Patients having fever over 38.0
2. Patients with infection
3. Patients with severe complications
4. Patients with double cancer
5. Patients with massive pleural effusion, ascites and pericardial fluid need to continuous drainage
6. Patients received chemotherapy including anthracycline
7. Patients with brain metastasis
8. Patient with previous hypersensitivity reaction to doxorubicin HCL or component of pegylated liposomal doxorubicin
9. Gravida, patients with lactation and with intent to pregnancy
10. Patients judged as the exclusive case by the investigator
86
1st name | |
Middle name | |
Last name | Junzo Kigawa |
Tottori University Hospital
Cancer Center
Nishimachi 36-1, Yonago, Tottori, Japan
0859
mshima12@med.tottori-u.ac.jp
1st name | |
Middle name | |
Last name | Muneaki Shimada |
Faculty of Medicine, Tottori University
Division of Reproductive-Perinatal medicine and Gynecologic Oncology
Nishimachi 36-1, Yonago, Tottori, Japan
0859-38-6647
mshima12@med.tottori-u.ac.jp
Japan Doxil study group
Gynecological Tumor Support Organization
Other
SGSG, TGCU, GOTIC
NO
2009 | Year | 05 | Month | 18 | Day |
Published
Completed
2009 | Year | 04 | Month | 22 | Day |
2009 | Year | 05 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2009 | Year | 05 | Month | 16 | Day |
2014 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002411
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