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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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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 |
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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 |
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Condition | |||
Condition | Gastric Cancer | ||
Classification by specialty |
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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 |
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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 |
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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 |
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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 |
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 1480 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
tuburayaa@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
miya@ecrin.or.jp |
Sponsor | |
Institute | Young Leaders' Program (YLP), Nagoya University School of Medicine
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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 | |
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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 |
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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. |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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 |
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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 | |
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Research case data | |
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