UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001976
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

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Basic information

Public 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

Acronym

Doxil trial

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

Scientific Title:Acronym

Doxil trial

Region

Japan


Condition

Condition

Recurrent/ Relapsed Müllerian carcinoma

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of more than grade2 hand-foot syndrome

Key secondary outcomes

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


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

Prevention

Type of intervention

Medicine Behavior,custom Maneuver

Interventions/Control_1

Local Cooling
Pridoxine treatment
Dexamethasone treatment
Education for patients

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Patients with recurrent/ relapsed M&uuml;llerian 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

Key exclusion criteria

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

Target sample size

86


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junzo Kigawa

Organization

Tottori University Hospital

Division name

Cancer Center

Zip code


Address

Nishimachi 36-1, Yonago, Tottori, Japan

TEL

0859

Email

mshima12@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Muneaki Shimada

Organization

Faculty of Medicine, Tottori University

Division name

Division of Reproductive-Perinatal medicine and Gynecologic Oncology

Zip code


Address

Nishimachi 36-1, Yonago, Tottori, Japan

TEL

0859-38-6647

Homepage URL


Email

mshima12@med.tottori-u.ac.jp


Sponsor or person

Institute

Japan Doxil study group

Institute

Department

Personal name



Funding Source

Organization

Gynecological Tumor Support Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

SGSG, TGCU, GOTIC

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2009 Year 05 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 04 Month 22 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2010 Year 04 Month 01 Day

Date trial data considered complete

2010 Year 10 Month 01 Day

Date analysis concluded

2010 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 05 Month 16 Day

Last modified on

2014 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002411


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name