UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047961 |
|---|---|
| Receipt number | R000054653 |
| Scientific Title | Association between adverse events and prognosis in postoperative adjuvant chemotherapy for colorectal cancer |
| Date of disclosure of the study information | 2022/06/06 |
| Last modified on | 2022/06/06 11:22:42 |
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Basic information
Public title
Association between adverse events and prognosis in postoperative adjuvant chemotherapy for colorectal cancer
Acronym
Association between adverse events and prognosis in postoperative adjuvant chemotherapy for colorectal cancer
Scientific Title
Association between adverse events and prognosis in postoperative adjuvant chemotherapy for colorectal cancer
Scientific Title:Acronym
Association between adverse events and prognosis in postoperative adjuvant chemotherapy for colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Molecular-targeted drugs for malignant tumors have become widespread, and there are reports on the relationship between the effects and the occurrence of adverse events such as skin disorders. On the other hand, there are few reports on the association between adverse events and recurrence in postoperative adjuvant therapy. Here, we use large-scale, reliable data to investigate the association between adverse events of postoperative adjuvant chemotherapy and recurrence-free survival in patients with colorectal cancer. The hypothesis is that the severer the adverse event, the less the recurrence, but conversely, the adjuvant therapy may not be completed and the recurrence may increase. In that case, evaluate the relationship between the number of adjuvant therapy courses and the prognosis.
We will also examine the onset and prognosis of capecitabine-related hand-foot syndrome. Existing studies have included cases treated with other antitumor drugs and radiation therapy, so the effects of capecitabine may be confounded by other factors. We believe that the data from JFMC37, a study of capecitabine monotherapy for stage III colon cancer, will provide a confounding-free analysis.
Basic objectives2
Others
Basic objectives -Others
Large-scale, reliable data will be used to investigate the association between postoperative adjuvant chemotherapy adverse events and recurrence-free survival in patients with colorectal cancer. We will also examine the onset and prognosis of capecitabine-related hand-foot syndrome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival
Overall survival
Adverse event
Compliance
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
The patients enrolled in clinical studies conducted by JFMC in the past (No.33, 35, 37,38, 41), those who received postoperative chemotherapy will be the target population for analysis.
Key exclusion criteria
-
Target sample size
4212
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 | 06 | Month | 06 | 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 | 03 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Relapse-free survival
Overall survival
Adverse event
Compliance
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054653
