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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000099
Receipt No. 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

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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
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

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
URL(English) https://upload.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


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