UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000282
Receipt number R000000352
Scientific Title Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer Step 2: low dose cisplatin given twice a week + S-1
Date of disclosure of the study information 2005/11/14
Last modified on 2010/07/16 13:15:27

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Basic information

Public title

Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
Step 2: low dose cisplatin given twice a week + S-1

Acronym

Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
(JFMC27-9902 Step2)

Scientific Title

Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
Step 2: low dose cisplatin given twice a week + S-1

Scientific Title:Acronym

Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
(JFMC27-9902 Step2)

Region

Japan


Condition

Condition

unresectable or recurrent gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of a newly scheduled combination therapy of S-1 with twice a week administration of low-dose cisplatin in patients with unresectable or recurrent gastric cancer, to determine the recommended dose (RD) and MTD, and to examine the efficacy of the treatment regimen at the RD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

adverse events, anti-tumor effect

Key secondary outcomes

pharmacokinetics of cisplatin,
overall 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

S-1 is administered orally at the dose of 40mg/m2 twice a day for 28 days, followed by 14 days rest.
Cisplatin is administered intravenously twice a week for 4 weeks, followed by 2 weeks rest.
The doses of cisplatin
1)7.5mg/m2/day x 2/week
2)10mg/m2/day x 2/week
3)15mg/m2/day x 2/week

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) Histologically or cytologically demonstrated unresectable or recurrent gastric cancer

2) With measurable or assessable legion(s)

3) Without prior anti-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible.

4) Adequate bone marrow, hepatic and renal function
(1)Hb >= 9.0 g/dl
(2)WBC 4,000 - 12,000/mm3
(3)neutrophils >= 2,000/mm3
(4)platelets >= 100,000/ mm3
(5)T-Bil <= 1.5mg/dl
(6)GOT, GPT <= 2.5 times of normal upper limits
(7)Al-p <= 2 times of normal upper limits
(8)BUN <= normal upper limits
(9)Cr<= normal upper limits
(10)CCr >= 50ml/min

5) ECOG performance status (PS) 0 to 1

6) Life expectancy longer than 3 months

7) Oral intake is possible

8) Written informed consent

Key exclusion criteria

1) severe complication(s)
2) symptomatic brain metastases
3) active double cancers
4) women who are currently pregnant, nursing, or plan to become pregnant
5) cases where the investigator disapproved of participation

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kosei Hirakawa

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Surgical Oncology

Zip code


Address

1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan

TEL

06-6645-3838

Email



Public contact

Name of contact person

1st name
Middle name
Last name Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Division name

Office

Zip code


Address

TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan

TEL

03-5627-7594

Homepage URL

http://www.jfmc.or.jp/

Email

jfmc-dc@jfmc.or.jp


Sponsor or person

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name



Funding Source

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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 14 Day


Related information

URL releasing protocol


Publication of results

Published


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

2003 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2003 Year 12 Month 01 Day

Last follow-up date

2009 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 11 Month 14 Day

Last modified on

2010 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000352


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name