UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000903
Receipt number R000001089
Scientific Title Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)
Date of disclosure of the study information 2007/11/24
Last modified on 2021/11/15 23:09:13

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Basic information

Public title

Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)

Acronym

OGSG 0703

Scientific Title

Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)

Scientific Title:Acronym

OGSG 0703

Region

Japan


Condition

Condition

Patients with unresectable or metastatic gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A new treatment methd will be developed using TS-1, CDDP and PTX for unresectable or metastatic gastric cancer. The recommendable use and dose should be decided through adverse events.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Adverse Events, maximum tolerated dose, recommended dose

Key secondary outcomes

Response Rate(RECIST)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

................Day1........day15.......day21.......day35
CDDP....*...............*
PTX........*...............*
TS-1......80, 100, 120mg/day.......interval
.................Day1 - day21............day22-day35

.....................One course takes 5 weeks.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) gastric cancer proven histologically
2) with measurable lesion or detectable lesion
3) without prior chemotherapy (radiation therapy, chemotherapy or hormone therapy)
Patients with the last prior therapy before more than 4 weeks of
registration can be registered.
4) sufficient function of important organs from the deta before 2 weeks of registration
O hemoglobin: >= 8.0 mg/dl
O WBC: >= 4,000 and =< 12,000/mm3
O Platelet: >= 100,000/mm3
O sGOT,sGPT: < 100 IU/L
O sT.bil.: <= 1.5 mg/dl
O sCreatinin: <= upper limit of each institute
*Creatinin clearance: >= 60 ml/min (Cockcroft-Gault method)
5) age: =>20 and 75=>
6) Performance Status: 0-1 (ECOG criteria)
7) more than 3 months of expected survival period
8) patients who can take food orally
9) written informed consent

Key exclusion criteria

1) with fresh intestinal bleeding
2) patient who cannot be administered anticancer agents due to intestinal obstraction
3) history of severe allergy against drug
4) with severe thoracic fluid and/or ascites
5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction or uncontrolled DM) which disturb registration to this study
6) with liver scirrhosis and/ or jaundice
7) patients with mental disprder who need medicines and/or treatments
8) with brain metastasis and its symptoms
9) with active double cancer
10) pregnant women or women who like to be pregnant
11) doctor's dicision not to be registered to this study

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimura Yutaka

Organization

NTT West Osaka Hospital

Division name

Dpt.Digestive Diseases

Zip code


Address

2-6-40Karasugatuji Tennnouji-Ku Osaka543-8922

TEL

06-6773-7111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Furukawa Hiroshi

Organization

Sakai City Hospital

Division name

Director

Zip code


Address

1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064

TEL

072-221-1700

Homepage URL


Email



Sponsor or person

Institute

OGSG

Institute

Department

Personal name



Funding Source

Organization

NPO Osaka Chinical Study Supporting Organization

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

2007 Year 11 Month 24 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

2007 Year 11 Month 02 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 Day

Last follow-up date

2009 Year 05 Month 01 Day

Date of closure to data entry

2009 Year 05 Month 01 Day

Date trial data considered complete

2009 Year 05 Month 01 Day

Date analysis concluded

2009 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 11 Month 22 Day

Last modified on

2021 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001089


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name