UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009395 |
|---|---|
| Receipt number | R000011037 |
| Scientific Title | Confirmatory Study of Oncotype DX Colon Cancer Assay to Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence in Patients with Resected Stage II and Stage III Colon Cancer |
| Date of disclosure of the study information | 2012/11/27 |
| Last modified on | 2014/06/26 09:51:17 |
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Basic information
Public title
Confirmatory Study of Oncotype DX Colon Cancer Assay to
Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence
in Patients with Resected Stage II and Stage III Colon Cancer
Acronym
SUNRISE
Scientific Title
Confirmatory Study of Oncotype DX Colon Cancer Assay to
Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence
in Patients with Resected Stage II and Stage III Colon Cancer
Scientific Title:Acronym
SUNRISE
Region
| Japan |
Condition
Condition
Colon Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm whether Oncotype DX Colon Cancer Assay predicts the risk of recurrence in patients with the StageII and StageIII colon cancer whom the surgical resection was done (surgery alone) in Japan
Basic objectives2
Others
Basic objectives -Others
To confirm whether Oncotype DX Colon Cancer Assay predicts the risk of recurrence in patients with the StageII and StageIII colon cancer whom the surgical resection was done (surgery alone) in Japan with cohort sampling design.
To classify the cases of cancer tissues of preservation FFPE into the low risk, the intermediate risk, and the high risk according to RS calculated with Oncotype DX Colon Cancer Assay.
To determine the relationship between RS and the risk of recurrence of Stage II and Stage III colon cancer (surgery alone).
To conduct univariate and the multivariate analyses using covariates of known clinicopathologic prognosis factors and MMR genes.
To examine whether RS can become the independent prognosis factor.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To consider the relationship between RS calculated by Oncotype DX Colon Cancer Assay in stage II and stage III colon cancer cases, and RFI* in Japanese.
Key secondary outcomes
To classify patients into the low risk, the intermediate risk, and the high risk according to RS, and test the hypothesis that the risk of recurrence of the patients of the high risk group is significantly high, compared with the patients of the low risk group.
To examine the prognosis factor (RFS, DFS and OS) using the cohort on step 1.
Relationship between RS and the risk of recurrence in a clinicopathologic factor.
Relationship between RS and Alternative Clinical Endpoints.
Relationship between Individual Genes, Gene groups, and Recurrence Risk.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who had stage II or stage III colon cancer surgery (including rectosigmoid cancer ) from 2000 to 2005 and who underwent resection of a colon cancer including lymph node dissection ≥ D2
(2) Patients who aged ≥20 and ≤80.
(3) Patients who are histologically diagnosed with primary colon adenocarcinoma
(4) Patients with sufficient FFPE sample
(5) Surgery alone (patients who had no Postoperative Chemotherapy)
Key exclusion criteria
(1)Patients who have previously the preoperative chemotherapy, immunotherapy or radiation therapy.
(2)Patients with appendix cancer
(3)Patients with history of a malignant tumor
(4)Patients with Familial Adenomatous Polyposis
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki YOSHINO |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwashi, Chiba 277-8577 JAPAN
TEL
04-7133-1111
sunrise@crsu.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuko MOURI |
Organization
Japan Clinical Research Support Unit
Division name
Coodinate Devision
Zip code
Address
Ochanomizu-Kimura Bldg. 3F2-19-3, Sotokanda, Chiyoda-ku, Tokyo101-0021 JAPAN
TEL
03-3254-8028
Homepage URL
http://www.crsu.org/
sunrise@crsu.org
Sponsor or person
Institute
Japan Clinical Research Support Unit
Institute
Department
Personal name
Funding Source
Organization
SRL, Inc.
Genomic Health Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN, US
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
国立がん研究センター東病院（千葉県）、静岡県立静岡がんセンター（静岡県）、埼玉県立がんセンター（埼玉県）、愛知県がんセンター中央病院（愛知県）、北里大学医学部（神奈川県）、大阪赤十字病院（大阪府）、関西ろうさい病院（大阪府)、四国がんセンター（愛媛県）、大阪医療センター（大阪府）、九州大学大学院（福岡県）、九州医療センター（福岡県）、北野病院（大阪府）、東京医科歯科大学大学院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.crsu.org/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.crsu.org/
Number of participants that the trial has enrolled
Results
RS
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Whether Oncotype DX Colon Cancer Assay predicts the risk of recurrence in patients with the StageII and StageIII colon cancer whom the surgical resection was done (surgery alone) in Japan?
Management information
Registered date
| 2012 | Year | 11 | Month | 26 | Day |
Last modified on
| 2014 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011037
