UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028787
Receipt number R000032946
Scientific Title Clinical study for advanced or metastatic soft tissue sarcoma of non-extremities treated with doxorubicin-based chemotherapy (a retrospective study)
Date of disclosure of the study information 2017/08/23
Last modified on 2017/08/23 14:43:42

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Basic information

Public title

Clinical study for advanced or metastatic soft tissue sarcoma of non-extremities treated with doxorubicin-based chemotherapy (a retrospective study)

Acronym

Clinical study for advanced or metastatic soft tissue sarcoma of non-extremitie

Scientific Title

Clinical study for advanced or metastatic soft tissue sarcoma of non-extremities treated with doxorubicin-based chemotherapy (a retrospective study)

Scientific Title:Acronym

Clinical study for advanced or metastatic soft tissue sarcoma of non-extremitie

Region

Japan


Condition

Condition

metastatic soft tissue sarcoma of non-extremities treated with doxorubicin-based chemotherapy in our institution

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal the efficacy of the doxorubicin based chemotherapy including monotherapy and combination therapy (CYVADIC, AI, and others) in patients with metastatic soft tissue sarcoma of non-extremities in our institution

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival for the patients with metastatic soft tissue sarcoma of non-extremities who were treated with doxorubicin based chemotherapy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with metastatic soft tissue sarcoma of non-extremities who were treated with doxorubicin based chemotherapy between October 2015 and April 2016 in our institution

Key exclusion criteria

not applicable

Target sample size

75


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunji Takahashi

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Department of Medical Oncology

Zip code


Address

3-8-31 Ariake, Tokyo, 135-8550

TEL

+81-3-3520-0111

Email

s.takahashi-chemotherapy@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shoko Marshall

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Department of Medical Oncology

Zip code


Address

3-8-31 Ariake, Tokyo, 135-8550

TEL

+81-3-3520-0111

Homepage URL


Email

shoko.masharu@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Institute

Department

Personal name



Funding Source

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

2017-1002

Org. issuing International ID_1

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 23 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2017 Year 05 Month 22 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a retrospective study with reviewing patients data


Management information

Registered date

2017 Year 08 Month 23 Day

Last modified on

2017 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032946


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name