UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047045 |
|---|---|
| Receipt number | R000053630 |
| Scientific Title | Validation of adjuvant chemotherapy for colorectal cancer in patients with renal dysfunction |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/28 16:53:58 |
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Basic information
Public title
Validation of adjuvant chemotherapy for colorectal cancer in patients with renal dysfunction
Acronym
Validation of adjuvant chemotherapy for colorectal cancer in patients with renal dysfunction
Scientific Title
Validation of adjuvant chemotherapy for colorectal cancer in patients with renal dysfunction
Scientific Title:Acronym
Validation of adjuvant chemotherapy for colorectal cancer in patients with renal dysfunction
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The number of cancer patients with renal dysfunction is increasing due to the aging society and comorbidities such as diabetes.
The choice of adjuvant chemotherapy for colorectal cancer patients with mild renal dysfunction is sometimes difficult to decide whether or not to take medication and whether or not to reduce the dose, considering the balance between the efficacy and adverse events.
If the creatinine clearance Ccr of the patients who participated in the clinical trial of colorectal cancer adjuvant chemotherapy using fluorinated pyrimidine is calculated, it is considered that not a few patients with mild renal dysfunction are enrolled.
In this study, we will select postoperative colorectal cancer patients with renal dysfunction, and classify the severity of chronic renal dysfunction according to Ccr.
The purpose of this study is to compare the incidence of adverse eventsof adjuvant chemotherapy, efficacy (recurrence), and survival with those of patients with normal renal function, and to verify its validity and usefulness.
Basic objectives2
Others
Basic objectives -Others
In this study, we will select postoperative colorectal cancer patients with renal dysfunction, and classify the severity of chronic renal dysfunction according to Ccr.
The purpose of this study is to compare the incidence of adverse eventsof adjuvant chemotherapy, efficacy (recurrence), and survival with those of patients with normal renal function, and to verify its validity and usefulness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items will be evaluated for each severity of chronic renal failure.
-overall survival
-relapse-free survival
-disease-free survival
-Time-to-treatment-failure
-Incidence of adverse events
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 21 | years-old | <= |
Age-upper limit
| 83 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All registered patients of clinical studies (JFMC33 / JFMC35 / JFMC37 / JFMC38 / JFMC41) conducted by JFMC in the past
Key exclusion criteria
-
Target sample size
4327
Research contact person
Name of lead principal investigator
| 1st name | Takaki |
| Middle name | |
| Last name | Yoshikawa |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Database Project Support Committee
Zip code
136-0071
Address
Tani Building 3F, 1-28-6 Kameido, Koto-ku, Tokyo
TEL
0356277594
jfmc-dc@jfmc.or.jp
Public contact
Name of contact person
| 1st name | Yukari/Masaru |
| Middle name | |
| Last name | Kawamura/Mutoh |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Data Management Section/Statistical Analysis Section
Zip code
136-0071
Address
Tani Building 3F, 1-28-6 Kameido, Koto-ku, Tokyo
TEL
0356277594
Homepage URL
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Epidemiological and Clinical research Information Network (ECRIN)
Address
21-7 Shogoin Sannocho Sakyo-ku, Kyoto-shi, Kyoto-fu 606-8392
Tel
075-762-1200
naomi.iwahori@ecrin.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items will be evaluated for each severity of chronic renal failure.
/overall survival
/relapse-free survival
/disease-free survival
/Time-to-treatment-failure
/Incidence of adverse events
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053630
