UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000285
Receipt number R000000365
Scientific Title Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
Date of disclosure of the study information 2005/11/18
Last modified on 2009/09/14 16:19:00

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Basic information

Public title

Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1

Acronym

Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1

Scientific Title

Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1

Scientific Title:Acronym

Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1

Region

Japan


Condition

Condition

senior citizen's gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine a clinical effect and safety of the TS-1 administering to inoperable or recurrent senior citizen's gastric cancer by 75 years old or more.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

TTF, OS, Safety, Home treatment period, home treatment rate


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

TS1: 50 or 80 or 100 or 120 mg/body/day, orally 28 days, every 6 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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)With pathologically proven gastric cancer
2) With at least one measurable lesion (RECIST)
3) Age 75 years old or more
4) ECOG performance status<=2
5) Sufficient organ functions
6) No prior chemotherapy
7) Life expectancy estimated>=3 months
8) With written informed consent
9) Case who has understanding that can secure S-1 compliance enough

Key exclusion criteria

1.History of severe drug allergic reaction
2.Severe Bone marrow suppression,renal and liver function disturbance
3.Concomitant therapy with another anticancer drug or flucytocine
4.Marked pleural effusion or ascites
5.Symptomatic brain metastasis
6.Intestinal fresh hemorrhage
7.Active secondary cancer
8.Accompanied serious diseases
9.Severe Ischemic heart disease or Arrhythmia which requires treatment
10.Watery diarrhea
11.Decision as ineligible by principal investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Kurihara

Organization

The Tokyo cooperative Oncology Group

Division name

Director

Zip code


Address

1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

The Tokyo cooperative Oncology Group

Division name

Secretariat

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

The Tokyo cooperative Oncology Group

Institute

Department

Personal name



Funding Source

Organization

The Tokyo cooperative 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

2005 Year 11 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.springerlink.com:80/content/h0w03400l76922m8/?p=9636b082bb344721ae0e0bfc46bf95ff&pi=1

Number of participants that the trial has enrolled


Results

Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7-37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes.

Conclusions:
The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.

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

2004 Year 05 Month 21 Day

Date of IRB


Anticipated trial start date

2004 Year 06 Month 01 Day

Last follow-up date

2007 Year 05 Month 01 Day

Date of closure to data entry

2007 Year 05 Month 01 Day

Date trial data considered complete

2007 Year 11 Month 01 Day

Date analysis concluded

2007 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 11 Month 18 Day

Last modified on

2009 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000365


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name