UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037487 |
|---|---|
| Receipt number | R000042735 |
| Scientific Title | Prospective observational study to develop the evaluation methods of the gastric cancer pathophysiology and the prediction methods of the anti-cancer therapy response. |
| Date of disclosure of the study information | 2019/07/29 |
| Last modified on | 2020/02/12 10:02:11 |
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Basic information
Public title
Prospective observational study to develop the evaluation methods of the gastric cancer pathophysiology and the prediction methods of the anti-cancer therapy response.
Acronym
Clinical study to develop the prediction methods of the anti-cancer therapy response.
Scientific Title
Prospective observational study to develop the evaluation methods of the gastric cancer pathophysiology and the prediction methods of the anti-cancer therapy response.
Scientific Title:Acronym
Clinical study to develop the prediction methods of the anti-cancer therapy response.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1.To clear my doubts why such patients responded or not to anti-cancer drug exists. Does this base on their pathophysiology?
2.And to solve my hypothesis was that if a new patient who has an identical or similar HLA profile as another patient who has survived for a long time is given the same treatment or drug, that new patient might also survive for a long time.
3.Exploratory research of predictors for the effectiveness of therapy.
Basic objectives2
Others
Basic objectives -Others
Exploratory research of predictors for the effectiveness of therapy.
Evaluation of QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival and QOL based on predictors.
Key secondary outcomes
HLA
APRs
Cellar immunity
QOL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary gastric cancer patients who gave informed consent and received the examination of HLA, APRs, cellular immunity, QOL questionnaire, and so on.
Patients refused to enroll in RCT or refuse to receive anti-cancer drugs, but want to receive some anti-cancer drugs selected by him/herself, or to HLA oriented therapy.
Drugs used were PSK,
F, MMC and CDDP.
Key exclusion criteria
N/A
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Mitomi |
Organization
Tokai University
Division name
Department of Surgery
Zip code
259-1193
Address
Bohseidai, Isehara, Kanagawa 259-1193, Japan.
TEL
0463-96-6163
ogoshi@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Kyoji |
| Middle name | |
| Last name | Ogoshi |
Organization
Tokai University
Division name
Department of Surgery
Zip code
259-1193
Address
Bohseidai, Isehara, Kanagawa 259-1193, Japan.
TEL
0463-96-6163
Homepage URL
ogoshi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
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
Tokai University
Address
Bohseidai, Isehara, Kanagawa 259-1193, Japan.
Tel
0463-96-6163
ogoshi@is.icc.u-tokai.ac.jp
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
東海大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Partially published
Result
URL related to results and publications
http://joi.jlc.jst.go.jp/JST.JSTAGE/acrt/19.44?from=CrossRef
Number of participants that the trial has enrolled
878
Results
The correlation between CEA and APRs was possible to predict the efficacy of PSK combination therapy.
Our results showed that patients with preoperative examination of HLA antigens were better survival than those without examination.
We, however, failed to find a specific HLA profile to treatment response.
Results date posted
| 2019 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male:Female=643:235
Median age (range): 60 years old (24-92 years old)
Participant flow
No. of patients given therapy
Gastrectomy alone 378
PSK 34
F 124
FPSK 193
M 53
MF 55
MFPSK 35
CF 7
CFPSK 1
Adverse events
Seven patients were died within 30 days after gastrectomy.
Outcome measures
Overall survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 1977 | Year | 09 | Month | 01 | Day |
Date of IRB
| 1977 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 1977 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recommended therapy
R0:
Stage 1: Gastrectomy alone/PSK
Stage 2-4: F/M/MF and/or PSK
R(+):
Chemotherapy: MF/CF and/or PSK
PSK was administered orally from 14 days after gastrectomy at a dose of 3.0g/day and at least at a dose of over 270g. Fluoropyrimidine prodrug (5-FU 150mg/day or UFT (300mg/day or TS1 40-80mg/day) was administered orally from 14 days after gastrectomy over 1 year. MMC was injected intravenously 0.4 mg/Kg and/or 0.2 mg/Kg intraoperatively, or within 1 month after gastrectomy. CDDP (40-60mg/m2/W 4 times) was administered intravenously after gastrectomy starting from July 1996.
The principles of this study outlined in the Declaration of Helsinki were followed.
The PSGP(UMINID000037472), JCTB(UMINID000037475), and JSCT(UMINID000037483) trials were performed to base on the results of this study. Results, including trials above were reported (Ann. Cancer Res. Therap. Vol. 19,44-53, 2011). As T. Mitomi passed away, an e-mail address of the principal investigator is that of K. Ogoshi.
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/07/25 | Tokai UMIN登録.xlsx |
