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
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/
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
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
