UMIN-CTR Clinical Trial

Public title

The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.

Acronym

The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.

Scientific Title

The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.

Scientific Title:Acronym

The analysis of treatment-related leukemia after taxan and platinum based chemotherapy, retrospective multicenter study.

Region

Japan

Condition

Gynecologic malignancies

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine incidence and clinical characteristics of treatment-related leukemia after taxan and platinum based chemotherapy.

Basic objectives2

Others

Basic objectives -Others

incidence

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Incidence of treatment-related leukemia after only taxan and platinum(Pt) based chemotherapy.

Key secondary outcomes

Incidence of TRL according to the combination of Taxan and Pt.
Relationship of total dose of Taxan and the Pt and the incidence of TRL.
Duration from the last chemotherapy to the TRL.
Characteristics of chromosomal abnormality and karyo
-type of TRL.
Treatment and outcome of TRL.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Patients with pathologically confirmed ovarian cancer, uterine body cancer, cervical cancer.
Patients provided taxan and Pt based chemotherapy from January, 2002 to December, 2006.
When taxan and Pt based chemotherapy was provided as neo adjuvant chemotherapy, it applies.
Patients without medical history of malignancies before taxan and Pt based chemotherapy.
Patients provided only taxan and Pt based chemotherapy.

Key exclusion criteria

Patients with radiation therapy.

Target sample size

5000

Name of lead principal investigator

1st name
Middle name
Last name	Toyomi Satoh

Organization

University of Tsukuba , Faculty of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

Address

1-1-1 Tennodai, Tsukuba Ibaraki, 305-8575, Japan

TEL

029-853-3073

Email

toyomi-s@md.tsukuba.ac.jp

Name of contact person

1st name
Middle name
Last name	Manabu Sakurai

Organization

University of Tsukuba , Faculty of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

Address

1-1-1 Tennodai, Tsukuba Ibaraki, 305-8575, Japan

TEL

029-853-3073

Homepage URL

http://www.md.tsukuba.ac.jp/clinical-med/ob-gyn/

Email

m-sakurai@md.tsukuba.ac.jp

Institute

Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC)

Institute

Department

Personal name

Organization

Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

04

Month

08

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A retrospective observational study

Name of primary sponsor
Gynecologic Oncology Trial and Investigation Consortium of North Kanto (GOTIC)

Key inclusion criteria
Patients with pathologically confirmed ovarian cancer, uterine body cancer, cervical cancer.
Patients provided taxan and Pt based chemotherapy from January, 2002 to December, 2006.
When taxan and Pt based chemotherapy was provided as neo adjuvant chemotherapy, it applies.
Patients without medical history of malignancies before taxan and Pt based chemotherapy.
Patients provided only taxan and Pt based chemotherapy.
Patients without radiation therapy.

Outcomes
Incidence of treatment-related leukemia after only taxan and platinum(Pt) based chemotherapy.
Incidence of TRL according to the combination of Taxan and Pt.
Relationship of total dose of Taxan and the Pt and the incidence of TRL.
Duration from the last chemotherapy to the TRL.
Characteristics of chromosomal abnormality and karyo
-type of TRL.
Treatment and outcome of TRL.

Registered date

2015

Year

07

Month

15

Day

Last modified on

2015

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021188