UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028678 |
|---|---|
| Receipt number | R000032831 |
| Scientific Title | Translational Research of Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine (RAINCLOUD) |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2021/09/01 14:43:33 |
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Basic information
Public title
Translational Research of Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine (RAINCLOUD)
Acronym
RAINCLOUD-TR
Scientific Title
Translational Research of Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine (RAINCLOUD)
Scientific Title:Acronym
RAINCLOUD-TR
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the clinical correlation between biomarkers (both relevant or other) and clinical outcome as the patients registerd the RAINCLOUD study.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma levels of VEGF-A,PlGF and VEGFR-1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Collecting blood 12mL at the time of before RAINCLOUD protocol treatment, and PD.
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) Approved to supply the samples for this study by Institutional Review Board
2) Written informed consent
Key exclusion criteria
1) Patients who are regarded as inadequate for study enrollment by investigators
2) Patients who refuse to supply the samples
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naotoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Osaka International Cancer Institute
Division name
Medical Oncology
Zip code
537-8511
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
sugimoto-na2@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Naotoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Osaka International Cancer Institute
Division name
Medical Oncology
Zip code
537-8511
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
sugimoto-na2@mc.pref.osaka.jp
Sponsor or person
Institute
MCSGO: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
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
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka
Tel
+81669451181
rinri@opho.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
| 2017 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032831
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
