UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020416 |
|---|---|
| Receipt number | R000023578 |
| Scientific Title | Regorafenib versus TAS-102 as Salvage-line in patients with colorectal cancer refractory to standard chemotherapies: a multicenter observational study |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2018/10/09 07:50:00 |
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Basic information
Public title
Regorafenib versus TAS-102 as Salvage-line in patients with colorectal cancer refractory to standard chemotherapies: a multicenter observational study
Acronym
Regorafenib versus TAS-102: a multicenter, retrospective observational study (REGOTAS)
Scientific Title
Regorafenib versus TAS-102 as Salvage-line in patients with colorectal cancer refractory to standard chemotherapies: a multicenter observational study
Scientific Title:Acronym
Regorafenib versus TAS-102: a multicenter, retrospective observational study (REGOTAS)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety between regorafenib alone and TAS-102 alone in patients with colorectal cancer refractory to standard chemotherapies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival, response rate, disease control rate, time to treatment failure, time to ECOG PS >=2, incidence of adverse events, detail of subsequent treatment, and comparison between patients with initial dose reduction and patients without it.
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) Patients who were treated with regorafenib or TAS-102 between 26th May 2014 and 30th September 2015.
2) Histologically proven colorectal adenocarcinoma
3) Unresectable colorectal cancer
4) Refractory to fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EFGR antibody (limited KRAS or RAS wild type)
5) With measurable or evaluable lesion
6) Age <=20 years old
7) ECOG PS 0 to 2
Key exclusion criteria
1) Prior therapy with regorafenib or TAS-102
2) Active infections
3) Symptomatic brain metastasis
4) Active double cancers
5) Serious complications
6) Uncontrolled thromboembolism
7) Comorbidity with systemic steroid therapy
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shimada |
Organization
Kochi Health Sciences Center
Division name
Division of Clinical Oncology
Zip code
Address
2125-1, Ike, Kochi city, Kochi
TEL
088-837-3000
yasuhiro_shimada@khsc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshikazu Moriwaki |
Organization
University of Tsukuba
Division name
Division of Gastroenterology
Zip code
Address
1-1-1, Tennodai, Tsukuba city, Ibaraki
TEL
029-853-3218
Homepage URL
tmoriwak@md.tsukuba.ac.jp
Sponsor or person
Institute
Japanese Society for Cancer of the Colon and Rectum
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Cancer of the Colon and Rectum
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
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
高知医療センター（高知県）、筑波大学（茨城県）、愛知県がんセンター（愛知県）、国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉健）、東京医科歯科大学（東京都）、静岡がんセンター（静岡県）、防衛医科大学校（埼玉県）、神戸大学（兵庫県）、九州大学（福岡県）、四国がんセンター（愛媛県）、九州がんセンター（福岡県）、千葉県がんセンター（千葉健）、北海道大学（北海道）、近畿大学（兵庫県）、埼玉県立がんセンター（埼玉県）、JHCO九州病院（福岡県）、大阪府立成人病センター（大阪府）、大阪大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://abstracts.asco.org/199/AbstView_199_182328.html
Number of participants that the trial has enrolled
Results
Whether unadjusted analysis or adjusted analysis was established, regorafenib and trifluridine/tipiracil showed a similar efficacy in the overall survival of? patients with metastatic colorectal cancer refractory to standard treatments in the real-world setting.
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
| 2015 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 09 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 30 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2016 | Year | 01 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023578
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