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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000037475 |
Receipt No. | R000042721 |
Scientific Title | Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy in gastric and colorectal cancer. |
Date of disclosure of the study information | 2019/07/29 |
Last modified on | 2019/07/24 |
Basic information | ||
Public title | Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy in gastric and colorectal cancer. | |
Acronym | Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy (JCTB trial). | |
Scientific Title | Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy in gastric and colorectal cancer. | |
Scientific Title:Acronym | Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy (JCTB trial). | |
Region |
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Condition | ||
Condition | Gastric cancer
Colorectal cancer |
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Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | Prediction of PSK immunotherapy response in patients with HLA B40 or B51. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Five year overall survival after gastrectomy |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Double blind -all involved are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment | Central registration |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | HLA B40(+)
HLA B51(+) |
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Interventions/Control_2 | PSK(-)
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. Per os fluoropyrimidine prodru (5-FU 150mg/day or UFT (300mg/day) was administered orally from 14 days after gastrectomy over 1 year. MMC was injected intravenously 0.4 mg/Kg intraoperatively and/or 0.2 mg/Kg on postoperative day 1. |
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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 | Primary T2-T4 gastric and colorectal cancer patients who gave informed consent.
MMC injection and the selection of F drugs was depended on an attending doctor. |
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Key exclusion criteria | 1. Double cancer.
2. Prior cytotoxic or radiation therapy. 3. Abnormal bone marrow, hepatic and renal function 4. Severe cardiac, hepatic and lung failure, and an attending doctor was considered unsuitable. |
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Target sample size | 600 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chiba University | ||||||
Division name | Department of Surgery | ||||||
Zip code | 263-8522 | ||||||
Address | 1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan | ||||||
TEL | 043-251-1111 | ||||||
iso2218@clock.ocn.ne.jp |
Public contact | |||||||
Name of contact person |
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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 | |
Institute | Japan cancer treatment and behavior study group(JCTB) |
Institute | |
Department |
Funding Source | |
Organization | Daiichi Sankyo Company
Kureha Chemical Industry |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Japan cancer treatment and behavior study group(JCTB) |
Address | 1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan |
Tel | 043-251-1111 |
iso2218@clock.ocn.ne.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | https://doi.org/10.4993%2Facrt.12.87 |
Publication of results | Partially published |
Result | |||||||
URL related to results and publications | https://doi.org/10.4993%2Facrt.12.87 | ||||||
Number of participants that the trial has enrolled | 432 | ||||||
Results | We failed to confirm that HLA B40 and B51 antigens significantly associated with response to PSK therapy. | ||||||
Results date posted |
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Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results | |||||||
Baseline Characteristics | Four hundred thirty two patients enrolled in this study. In gastric cancer, median age (range) was 60 years old (25-86 years old), and male and female, 230 and 93, respectively, and in colon cancer 63 years old (36-90 years old) and 57 and 52, respectively. | ||||||
Participant flow | Four hundred fourteen patients were assigned to therapy groups according to HLA B40 and B51 as follows;
Gastric cancer Colon cancer B40(+) MF 48 MFPSK 50 MF 20 MFPSK 17 B51(+) MF 32 MFPSK 25 MF 6 MFPSK 6 B40(-) MF 110 MFPSK 97 MF 41 MFPSK 30 B51(-) MF 126 MFPSK 122 MF 55 MFPSK 41 |
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Adverse events | not particular | ||||||
Outcome measures | Overall survival | ||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | JCTB Research board discussed our research protocol based on the principles outlined in the Declaration of Helsinki. |
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=R000042721 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |
2019/07/25 | JCTB UMIN胃大腸登録.xlsx |