UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000099
Receipt number R000000145
Scientific Title A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy
Date of disclosure of the study information 2005/08/31
Last modified on 2010/03/16 17:35:39

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Basic information

Public title

A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy

Acronym

A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy (JFMC31-0301)

Scientific Title

A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy

Scientific Title:Acronym

A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy (JFMC31-0301)

Region

Japan


Condition

Condition

Advanced or recurrent gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We compare the effect and toxicity between tailored dose CPT-11/S-1 combination, which is dose adjustments using a maximum dose-limiting toxicity of grade 2 or 3 in order to improve compliance and drug administration period, and standard S-1 administration in a randomized phase II trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Response duration, Time to progression (TTP), Overall survival, Incidence of adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Arm A (tailored CPT-11 + S-1): CPT-11 (75mg/m2) is given biweekly for 4 weeks (one cycle). If the manifested toxicity defined by NCI-CTC criteria, is 0 or 1 (grade 0 for diarrhea) during the first cycle, increase 25mg/m2 of CPT-11 to 100mg/m2, if grade 2 toxicity (grade 1 for diarrhea) is observed, maintain the same dose, and if toxicities of grade 3 (grade 2 for diarrhea) and more is shown, decrease 25mg/m2 of CPT-11 to 50mg/m2 for the second cycle. We repeat the dose adjustment every cycle in the same manner. S-1 is given one of the following doses twice daily, after breakfast and dinner; body surface area <1.25m2, 40mg; 1.25-1.50m2, 50mg; >=1.5m2, 60mg. S-1 is administered at the respective dose for 14 days, followed by a 14days rest period (one cycle).

Interventions/Control_2

Arm B (S-1): S-1 is given in the same dose of Arm A, and administered for 28 days, followed by a 14days rest period (one cycle).

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) Histologically demonstrated adenocarcinoma of the stomach
2) Failed operation or recurrence of gastric cancer
3) Measurable or assessable lesions
4) No prior therapy including radiation and/or chemotherapy except adjuvant chemotherapy after the preceding curative resection
5) Expected survival over 12 weeks
6) ECOG performance status 0-1
7) Sufficient organ functions
8) Written informed consent

Key exclusion criteria

1) History of using S-1
2) Medical history of allergy or hypersensitivity reactions to any drug
3) Serious effusion of cancerous fluids such as pleural effusion and/or ascites
4) Serious infectious disease
5) Diarrhea
6) Ileus or colon dysfunction
7) Lung fibrosis
8) Intake of flucitosine
9) Synchronous or metachronous or other types of malignancies
10) Uncontrollable diabetes mellitus
11) Serious heart disease
12) Serious psychological disease
13) Pregnancy
14) Patients judged inappropriate for this study by the physicians

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Kitajima

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

Shinanomachi 35, Shinjuku-ku, Tokyo, 160-8582, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

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 08 Month 31 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 06 Month 20 Day

Date of IRB


Anticipated trial start date

2003 Year 08 Month 01 Day

Last follow-up date

2007 Year 03 Month 01 Day

Date of closure to data entry

2007 Year 08 Month 01 Day

Date trial data considered complete

2007 Year 10 Month 01 Day

Date analysis concluded

2007 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 31 Day

Last modified on

2010 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name