UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001364
Receipt number R000001402
Scientific Title Phase II trial of TS-1 and cisplatin in patients with Carcinoma of Unknown Primary Sites (KMOG 0607)
Date of disclosure of the study information 2008/09/09
Last modified on 2017/02/27 16:03:36

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Basic information

Public title

Phase II trial of TS-1 and cisplatin in patients with Carcinoma of Unknown Primary Sites (KMOG 0607)

Acronym

Phase II trial of TS-1/Cisplatin in patients with CUPS (KMOG 0607)

Scientific Title

Phase II trial of TS-1 and cisplatin in patients with Carcinoma of Unknown Primary Sites (KMOG 0607)

Scientific Title:Acronym

Phase II trial of TS-1/Cisplatin in patients with CUPS (KMOG 0607)

Region

Japan


Condition

Condition

Carcinoma of Unknown Primary Sites

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of TS-1 and cisplatin in patients with carcinoma of unknown primary sites

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Safety, Overall survival, Progression free survival


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment: TS-1+CDDP

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Histological confirmation of cancer
(2)Cancer of unknown primary sites
(3)Measureable disease
(4)ECOG PS 0~2
(5)Adequate major organ function
(6)All patients provided written informed consent.

Key exclusion criteria

(1)Massive pleural effusion or massive ascites
(2)Symptomatic brain metastases

Target sample size

38


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eishi Baba

Organization

Kyushu University Hospital

Division name

Division of Hematology and Oncology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan

TEL

092-642-5232

Email

e-baba@intmed1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Kusaba

Organization

Kyushu University Hospital

Division name

Division of Hematology and Oncology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan

TEL

092-642-5232

Homepage URL


Email

hkusaba@intmed1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu Medical Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Kyushu Medical Oncology Group

Organization

Division

Category of Funding Organization

Self funding

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

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

2008 Year 09 Month 09 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

2006 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2006 Year 07 Month 14 Day

Last follow-up date

2016 Year 12 Month 01 Day

Date of closure to data entry

2016 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2008 Year 09 Month 09 Day

Last modified on

2017 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001402


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name