UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000082
Receipt number 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 17:06:46

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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