UMIN-CTR Clinical Trial

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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