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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004419 |
Receipt No. | R000005276 |
Scientific Title | Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer. |
Date of disclosure of the study information | 2010/10/28 |
Last modified on | 2017/05/01 |
Basic information | ||
Public title | Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer. | |
Acronym | Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer | |
Scientific Title | Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer. | |
Scientific Title:Acronym | Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer | |
Region |
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Condition | |||
Condition | Advanced gastric cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the efficacy and safety of the long immunochemotherapy treatment using PSK+TS-1 for advanced gastric cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Relapse-Free Survival 5years |
Key secondary outcomes | Overall Survival 5years
Drug compliance Adverse events Serial changes of tumor markers |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 1.TS-1 80 mg/m2, PO from day 1 to day 28 of each 42 day cycle.
2.PSK 3g, PO from day 1 to 2 years. |
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Interventions/Control_2 | ||
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.Patient who is pathologically confirmed as gastric cancer
2.Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B 3.Patient whose final stage is II (except for T1), IIIA, or IIIB 4.Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis 5.Patient whose age at the registration is ranging between 20 and 80 years old 6.Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy 7.Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration 8.Patient who has no serious concurrent complications, and satisfies the following criteria 9.White blood cell count>= 4,000 /mm3 10.Platelet count: >= 100,000 /mm3 11.Serum total bilirubin: <= 1.5 mg/dL 12.Serum AST (GOT), ALT (GPT): < 2.5 * ULN 13.Serum creatinine: < ULN 14.Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study |
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Key exclusion criteria | 1.Patient with metachronous or synchronous multicancer
2.Patient who contraindicates to TS-1 3.Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium 4.Patient who has experienced serious drug allergy over grade 3 in the past 5.Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency 6.Patient with diarrhea (watery stool) 7.Patient who is pregnant or in lactation, or wish to become pregnant during this study 8.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 | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Toho University School of Medicine | ||||||
Division name | Department of Surgery | ||||||
Zip code | |||||||
Address | 6-11-1 Omori-Nishi, Ota-ku, Tokyo | ||||||
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 | Department of Surgery | ||||||
Zip code | |||||||
Address | 6-11-1 Omori-Nishi, Ota-ku, Tokyo | ||||||
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=R000005276 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |