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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004466 |
Receipt No. | R000005324 |
Scientific Title | A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer. |
Date of disclosure of the study information | 2010/10/28 |
Last modified on | 2017/05/01 |
Basic information | ||
Public title | A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer. | |
Acronym | A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer. | |
Scientific Title | A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer. | |
Scientific Title:Acronym | A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer. | |
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 | The aim is to evaluate the clinical pathology effects of TS-1 plus cisplatin as a neoadjuvant chemotherapy against resectable gastric cancer. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The effect of the tumor reduction of providing by the chemotherapy effect judgment standard is used.
The doctor in charge judges the effect of the tumor reduction based on RECIST(http://www.recist.com/recist-in-practice/22.html) version 1.1. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | TS-1: Day1-21, p.o. and CDDP: Day8.
1 course takes 35 days. 1 course |
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Interventions/Control_2 | TS-1: Day1-21, p.o. and CDDP: Day8.
1 course takes 35 days. 2 courses |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
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 | 1.Primary gastric adenocarcinoma
2.The pathological material of the gastric carcinoma before chemotherapy 3.M (-),H (-),c-StageIII and IV in the staging classification 4.Adjustment of Neoadjuvant chemotherapy with TS-1+CDDP 5.Measurable lesions according to RECIST guidelines 6.No history of pretreatment (radiotherapy, chemotherapy,etc.) except surgery 7.PS(ECOG) is 0-2 8.Adequate organ function WBC>=4000/mm3 Neutrophil count>=2,000/mm3 Platelet count>=100,000/mm3 Hemoglobin>=8.0 g/dL 9.Liver function tests AST (GOT) and ALT (GPT) <=100IU/L Total bilirubin<=2.0 mg/dL 10.Renal function test CCr(e-GFR)>=60ml/min Serum creatinine<=1.50 mg/dL 11.Age 20 to 80 years old 12.With written informed consent |
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Key exclusion criteria | 1.Metachronous or synchronous multiple cancer
2.Pregnant or in lactation. 3.Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge. |
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Target sample size | 110 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Toho University School of Medicine | ||||||
Division name | Division of general and Gastroenterological Surgery,Department of Surgery(Omori) | ||||||
Zip code | |||||||
Address | 6-11-1 Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan | ||||||
TEL | 03-3762-4151 | ||||||
hideaki.shimada@med.toho-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Toho University School of Medicine | ||||||
Division name | Division of general and Gastroenterological Surgery,Department of Surgery(Omori) | ||||||
Zip code | |||||||
Address | 6-11-1 Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan | ||||||
TEL | 03-3762-4151 | ||||||
Homepage URL | |||||||
hideaki.shimada@med.toho-u.ac.jp |
Sponsor | |
Institute | Toho University |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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=R000005324 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |