UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002785
Receipt number R000003381
Scientific Title A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Date of disclosure of the study information 2009/11/19
Last modified on 2022/12/08 22:07:25

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Basic information

Public title

A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)

Acronym

A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)

Scientific Title

A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)

Scientific Title:Acronym

A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)

Region

Japan


Condition

Condition

advanced and/or metastatic gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the feasibility and effectiveness of TS-1 plus Docetaxel for aged patients with advanced and/or metastatic gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate (RECIST)

Key secondary outcomes

Adverse Events/Incidence of AE.
Overall survival
Progression Free Survival
Time to Treatment Failure


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

Docetaxel and TS-1 (DS):A course includes docetaxel 40 mg/m2 on day 1 and TS-1 80 mg/m2/day for 14 days followed by 7 days of interval. Patients undergo repeats of this 3 week therapy until diagnoses of PD and/or untolerable adverse events or patients request to stop.

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric cancer
2) with measurable lesions for RECIST criteria
3) Patients older than 75 years
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
5) Patients who can intake orally
6) Patients' labo data within normal range
WBC:Between 4,000/mm3 and 12,000/mm3
Neutrocyte:More than 2,000/mm3
Hb:More than 8.0g/dL
Platelet:More than 100,000/mm3
Total bil.:Less than 1.5mg/dL
AST(GOT)ALT(GPT):Less than 2.5 times of upper normal range
Ccr:More than 40 mL/min
7) Patients without any prior chemotherapy are eligible and patients without any adverse events due to prior chemotherapy completed before 6 months are also eligible.
8) A predicted life expectancy of at least 3 months.
9) Written informed consent to participate in this study.

Key exclusion criteria

1) Patients with active double cancers
2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, uncontrolled DM, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
3) Patients with ascites and/or pleural fluid
4) Patients with any symptoms due to metastases to the central nervous system
5) Patients with any fresh bleeding from digestive tract
6) with severe ischemic cardiac diseases or arythmia which needs treatments
7) Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray and/or CT
8) History of serious drug hypersensitivity due to 5-FU, Docetaxel or Polysolbate 80
9) Patients with severe dysfunction of kidney, bone marrow and/or liver
10) Patients who need flucitosine, fenitoin or walfarin
11) Patients with untreated edema
12) Any other patient whom the physician in charge of the study judges to be unsuitable.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Imamura Hiroshi

Organization

Toyonaka Municipal Hospital

Division name

Dpt.Surgery

Zip code


Address

4-14-1,Shibaharacho,Toyonaka, 560-8565

TEL

06-6843-0101

Email

imamurahiroshisakai@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Furukawa Hiroshi

Organization

Kinki University Faculty of Medicen

Division name

Department of surgery

Zip code


Address

377-2, Onohigashi, Osakasayama, Osaka, Japan

TEL

072-366-0221

Homepage URL


Email

imamurahiroshisakai@yahoo.co.jp


Sponsor or person

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (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

市立堺病院(大阪府)、八尾市立病院(大阪府)、大阪労災病院(大阪府)、市立吹田市民病院(大阪府)、大阪医療センター(大阪府)、関西電力病院(大阪府)、ベルランド総合病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、箕面市立病院(大阪府)


Other administrative information

Date of disclosure of the study information

2009 Year 11 Month 19 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

31

Results


Results date posted


Results Delayed

Delay expected

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 09 Month 01 Day

Date of IRB

2009 Year 12 Month 01 Day

Anticipated trial start date

2010 Year 02 Month 05 Day

Last follow-up date

2016 Year 01 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 28 Day


Other

Other related information



Management information

Registered date

2009 Year 11 Month 19 Day

Last modified on

2022 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003381


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name