![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031675 |
Receipt No. | R000036181 |
Scientific Title | Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))" |
Date of disclosure of the study information | 2018/03/12 |
Last modified on | 2021/01/18 |
Basic information | ||
Public title | Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))" | |
Acronym | Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))" | |
Scientific Title | Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))" | |
Scientific Title:Acronym | Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))" | |
Region |
|
Condition | |||
Condition | Gastric cancer | ||
Classification by specialty |
|
||
Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to identify predictive markers for docetaxel or S-1 in resectable gastric cancer. |
Basic objectives2 | Bio-availability |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | To evaluate if TUBB3 expression serves as a predictor for docetaxel by analyzing PFS and OS in docetaxel plus S-1 arm and S-1 alone arm according to TUBB3 status. |
Key secondary outcomes | To evaluate associations of PFS and OS with TS, DPYD, OPRT, and TYMP expression in S-1 alone arm.
To investigate correlation of PFS and OS with gene expression or mutations in each arm. |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients who are registered in JACCRO GC-07 trial (UMIN 000010337), include the following:
(1) Resected tumor tissue samples available (2) Approved to supply the tissue sample for this study by IRB. |
|||
Key exclusion criteria | (1) Patients who are considered as inadequate for study enrollment by investigators.
(2) Patients who refuse the use of samples for study. |
|||
Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | St. Marianna University School of Medicine | ||||||
Division name | Department of Clinical Oncology | ||||||
Zip code | 216-8511 | ||||||
Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan | ||||||
TEL | 044-977-8111 | ||||||
y.sunakawa@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Japan Clinical Cancer Research Organization (JACCRO) | ||||||
Division name | Office | ||||||
Zip code | 101-0051 | ||||||
Address | 6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051 | ||||||
TEL | 03-6811-0433 | ||||||
Homepage URL | |||||||
gc07.dc@jaccro.or.jp |
Sponsor | |
Institute | Japan Clinical Cancer Research Organization (JACCRO) |
Institute | |
Department |
Funding Source | |
Organization | Japan Clinical Cancer Research Organization (JACCRO |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Japan Clinical Cancer Research Organization Institutional Review Board |
Address | 6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051 |
Tel | 03-6811-0433 |
irb-jaccro@jaccro.or.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 | 聖マリアンナ医科大学(神奈川県)他 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | This is a translational study to identify novel biomarkers for adjuvant chemotherapy in resectable gastric cancer using tissue samples of the JACCRO GC-07 trial (START-2). |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036181 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |