Unique ID issued by UMIN | C000000082 |
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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 |
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
Phase III trial of postoperative adjuvant oral fluoropyrimidine (UFT or S1) vs. sequential paclitaxel (Factorial Design)for T3/4 gastric carcinoma: the SAMIT Trial
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
Phase III trial of postoperative adjuvant oral fluoropyrimidine (UFT or S1) vs. sequential paclitaxel (Factorial Design)for T3/4 gastric carcinoma: the SAMIT Trial
Japan |
Gastric Cancer
Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
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.
Bio-equivalence
Confirmatory
Pragmatic
Phase III
Disease- free survival
Incidence of adverse events, overall survival and proportion of patients who completed the protocol treatment.
Interventional
Factorial
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
4
Treatment
Medicine |
UFT alone UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x6
S1 alone(control)
S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x8
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
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
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
1480
1st name | |
Middle name | |
Last name | Akira Tsuburaya |
Kanagawa Cancer Center
Department of Gastrointestinal Surgery
1-1-2, Nakao, Asahi-ku, Yokohama, 2410815, Japan
045-391-5761
tuburayaa@gmail.com
1st name | |
Middle name | |
Last name | Yumi Miyashita |
Epidemiological and Clinical Research Information Network (ECRIN)
Aichi Devision
348-2F, Kouseicho, Okazaki, 4440052, Aichi
0564-66-1220
miya@ecrin.or.jp
Young Leaders' Program (YLP), Nagoya University School of Medicine
Epidemiological and Clinical Research Information Network (ECRIN)
Non profit foundation
EBM Cooperative Research Center, Kyoto University
NO
2005 | Year | 09 | Month | 01 | Day |
http://jjco.oxfordjournals.org/cgi/reprint/35/11/672
Partially published
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70025-7/abstract
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.
No longer recruiting
2004 | Year | 05 | Month | 24 | Day |
2004 | Year | 08 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
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
2005 | Year | 08 | Month | 28 | Day |
2014 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000076
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