UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028784 |
|---|---|
| Receipt number | R000032398 |
| Scientific Title | Registry Study to Assess Decision Impact of the Oncotype DX Colon Recurrence Score on Adjuvant Treatment Recommendations in Stage II and Stage IIIA/B Colon Cancer in Japan |
| Date of disclosure of the study information | 2017/08/23 |
| Last modified on | 2019/08/07 18:24:34 |
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Basic information
Public title
Registry Study to Assess Decision Impact of the Oncotype DX Colon Recurrence Score on Adjuvant Treatment Recommendations in Stage II and Stage IIIA/B Colon Cancer in Japan
Acronym
SUNRISE-DI
Scientific Title
Registry Study to Assess Decision Impact of the Oncotype DX Colon Recurrence Score on Adjuvant Treatment Recommendations in Stage II and Stage IIIA/B Colon Cancer in Japan
Scientific Title:Acronym
SUNRISE-DI
Region
| Japan |
Condition
Condition
Stage II and Stage IIIA/B Colon Cancer in Japan
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Assess changes in physicians treatment recommendations for stage II and stage IIIA/B patients who have been selected by treating physicians to receive the Oncotype DX Colon Cancer Assay
Basic objectives2
Others
Basic objectives -Others
The proportion of treatment recommendations that change in patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess the changing rate of the adjuvant chemotherapy regimen after discussing the result of the Oncotype DX Colon Cancer Assay
Key secondary outcomes
1.The proportion of treatment recommendations that change in patients with stage II colon cancer
2.The proportion of treatment recommendations that change in patients with stage IIIA/B colon cancer
3.For each stage of disease (stage II and stage IIIA/B), the proportion of recommendations for observation only, Fluoropyrimidine-based chemotherapy or Fluoropyrimidine-based plus Oxaliplatin chemotherapy by RS defined groups at pre- and post-assay timepoints
4.Differences in the expressed level of confidence in the treatment recommendation as measured by the responses to the item regarding physician confidence in the pre- and post-assay questionnaires for all patients and for patients within each stage of disease (stage II and stage IIIA/B tumors)
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
1. Physician who makes adjuvant chemotherapy treatment recommendations and delivers treatments to patients with stage II or stage III Japanese colon cancer (including Recto-sigmoid colon cancer)
2. Treating physician determines that Oncotype DX testing may contribute to adjuvant decision making for the patient.
3. Patient is willing to consider receiving or not receiving Fluoropyrimidine based plus oxaliplatin adjuvant chemotherapy based on the results of the Oncotype DX assay.
4. Patient must be Japanese and 20 years or older.
5. ECOG Performance Status 0 or 1.
6. Pathologically confirmed colon adenocarcinoma as a primary focus.
7. Surgical and resected specimen findings confirm that the main tumor located at caecum, colon, and recto-sigmoid colon.
8. Tumor has completely resected with both macroscopically and microscopically.
9. The final staging is either Stage II, stage IIIA , or stage IIIB colon cancer.
10. Must be a candidate for treatment of their cancer with systemic adjuvant chemotherapy, including Fluoropyrimidine plus oxaliplatin chemotherapy and can start treatment within 8 weeks after operation.
11. Must have sufficient invasive colon cancer tissue available for submission to Genomic Health in accordance with the Oncotype DX Pathology Guidelines (to be made available upon study initiation).
12. Patient has signed the Informed Consent Form.
Key exclusion criteria
1.A past history of colon cancer prior to the current diagnosis. Patients who had completely endoscopically resected intra mucosal cancer (gastric, colon and esophagus), cured cervical cancer, cured skin basal cell carcinoma, and skin squamous cell carcinoma with more than 5 years of DFS can be included.
2.Simultaneous multiple/ double cancer
3.previous radiation therapy to the site of tumor tissue
4.Perforations or obstructions related to current diagnosis
5.Previous history of neo-adjuvant or adjuvant chemotherapy using Fluoropyrimidine based or platina based chemotherapy for cancer (except hormonal therapy).
6.Known DPD deficiency.
7.Known MMR-D (MSI-H) by local assessment.
8.Physician determines that the patient is not appropriate as a candidate.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeharu Yamanaka |
Organization
Yokohama City University School of Medicine
Division name
Department of Biostatistics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2311
yamanaka@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayoko Nakashima |
Organization
Yokohama City University hospital
Division name
YCU Center for Novel and Exploratory Clinical Trials
Zip code
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-370-7994
Homepage URL
sayoko_n@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University school of Medicine, Department of Biostatistics
Institute
Department
Personal name
Funding Source
Organization
Genomic Health, Inc.
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
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
| 2017 | Year | 08 | Month | 23 | Day |
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
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The proportion of treatment recommendations that change across all patients (stage II and stage IIIA/B) from baseline (pre-assay) to follow-up (post-assay) based on responses to the treatment recommendation questions in the physician questionnaires. A change in treatment plan is defined as any of the following treatment recommendation changes.
Management information
Registered date
| 2017 | Year | 08 | Month | 23 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032398
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| Registered date | File name |
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