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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000082
Receipt No. R000000076
Scientific Title A randomized phase III trial of postoperative adjuvant oral fluoropyrimidine vs. sequential paclitaxel / oral fluoropyrimidine; and UFT vs. S1 for T3 / T4 gastric carcinoma: the Stomach Cancer Adjuvant Multi-institutional Trial Group (SAMIT) Trial
Date of disclosure of the study information 2005/09/01
Last modified on 2014/10/15

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Basic information
Public title A randomized phase III trial of postoperative adjuvant oral fluoropyrimidine vs. sequential paclitaxel / oral fluoropyrimidine; and UFT vs. S1 for T3 / T4 gastric carcinoma:
the Stomach Cancer Adjuvant Multi-institutional Trial Group (SAMIT) Trial
Acronym Phase III trial of postoperative adjuvant oral fluoropyrimidine (UFT or S1) vs. sequential paclitaxel (Factorial Design)for T3/4 gastric carcinoma: the SAMIT Trial
Scientific Title A randomized phase III trial of postoperative adjuvant oral fluoropyrimidine vs. sequential paclitaxel / oral fluoropyrimidine; and UFT vs. S1 for T3 / T4 gastric carcinoma:
the Stomach Cancer Adjuvant Multi-institutional Trial Group (SAMIT) Trial
Scientific Title:Acronym Phase III trial of postoperative adjuvant oral fluoropyrimidine (UFT or S1) vs. sequential paclitaxel (Factorial Design)for T3/4 gastric carcinoma: the SAMIT Trial
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A randomized phase III trial with two-by-two factorial design was conducted to elucidate survival benefit of sequential use of paclitaxel followed by oral fluoropyrimidines in comparison with fluoropyrimidines alone, and to compare the most commonly used two oral fluoropyrimidines, UFT and S1.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Disease- free survival
Key secondary outcomes Incidence of adverse events, overall survival and proportion of patients who completed the protocol treatment.

Base
Study type Interventional

Study design
Basic design Factorial
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 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT alone UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x6
Interventions/Control_2 S1 alone(control)
S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x8
Interventions/Control_3 Paclitaxel- UFT sequential
Paclitaxel 80 mg/m2 Day 1, 8 for the first 3 weeks, Day 1, 8, 15 every 4 weeks;
14 day interval
UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x3
Interventions/Control_4 Paclitaxel- TS-1 sequential
Paclitaxel 80 mg/m2 Day 1, 8 for the first 3 weeks, Day 1, 8, 15 every 4 weeks;
14 day interval
S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x4
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 Histologically proven adenocarcinoma of the stomach
Clinical and surgical findings of T3 or T4, N0-2, P0, M0
Underwent D2, D1 + #7 or D1 + #7-8 gastrectomy (R0 or R1)
No prior chemotherapy or radiotherapy
Age ranging between 20 and 80
Preoperative ECOG performance status 0-1
Sufficient organ functions before chemotherapy
Able to start chemotherapy between 14 and 56 days after surgery
Without synchronous or metachronous cancer (synchronous multiple cancers in the stomach included)
Written informed consent.
Recovered from or no operative complications
Oral food intake possible
Laboratory data
WBC >/= 3,000 /mm3 and </=12,000 /mm3 neutrocytes >/=1,500 / mm3
Platelets >/=100,000 /mm3
hemoglobin >/=8.0 g/dL
Albumin >/=3.0 g/dL;
GOT </=100 IU; GPT </=100 IU
Bilirubin </=1.5 mg/dL
Creatinine </=1.5 mg/dL
Key exclusion criteria Serious complications including ischemic heart disease and arrhythmia which require treatment
History of myocardial infarction in 6 months
Liver disease under treatment
Pneumonitis or lung fibrosis in need for oxygen therapy
Gastrointestinal bleeding in need for repeated blood transfusion
Psychological disease which require treatment
Diabetes mellitus under treatment
Bowel obstruction or ileus
Medical history of allergy or hypersensitivity to any drugs
Hypersensitivity to Cremophor EL
Acute inflammation
Pregnancy
Synchronous malignancies that may affect survival or adverse events
Patients judged inappropriate for the study by the physicians
Target sample size 1480

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tsuburaya
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 1-1-2, Nakao, Asahi-ku, Yokohama, 2410815, Japan
TEL 045-391-5761
Email tuburayaa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Miyashita
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Division name Aichi Devision
Zip code
Address 348-2F, Kouseicho, Okazaki, 4440052, Aichi
TEL 0564-66-1220
Homepage URL
Email miya@ecrin.or.jp

Sponsor
Institute Young Leaders' Program (YLP), Nagoya University School of Medicine
Institute
Department

Funding Source
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor EBM Cooperative Research Center, Kyoto University
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 09 Month 01 Day

Related information
URL releasing protocol http://jjco.oxfordjournals.org/cgi/reprint/35/11/672
Publication of results Partially published

Result
URL related to results and publications http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70025-7/abstract
Number of participants that the trial has enrolled
Results 
The 3-year DFS probability of the monotherapy group was 54.0% (95% confidence interval [CI], 50.2 - 57.6) and that of the sequential group was 57.2% (95% CI, 53.4 - 60.8; hazard ratio, 0.92 [95% CI, 0.80-1.07], p=.273). The 3-year DFS of the UFT group was 53.0% (95% CI, 49.2-56.6) and that of the S-1 group was 58.2% (95% CI, 54.4-61.8; hazard ratio, 0.81, p=.0048; p=0.151 for non-inferiority of UFT to S-1). Completion of protocol treatment was 61.5% and 70.3% for the monotherapy and sequential groups, respectively. 

Sequential paclitaxel did not improve DFS and non-inferiority of UFT was rejected; while S-1 was superior to UFT as adjuvant treatment for T4a or T4b gastric cancer. S-1 monotherapy remains a standard in Japan.
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 No longer recruiting
Date of protocol fixation
2004 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2004 Year 08 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 01 Month 01 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information Associate research:
1. Feasibility study for chemosensitivity assay-oriented individual chemotherapy
Primary investigator: Yasuhiro Kodera
2. Group-comparison between treatments in terms of patients' quality of life.

Advisory board:
Marc Buyse, Belgium
John F MacDonald, USA

Management information
Registered date
2005 Year 08 Month 28 Day
Last modified on
2014 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000076

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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