UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047044 |
|---|---|
| Receipt number | R000053627 |
| Scientific Title | Usefulness of postoperative adjuvant chemotherapy in patients with colorectal cancer T1/T2, N(+) |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/28 15:46:06 |
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Basic information
Public title
Usefulness of postoperative adjuvant chemotherapy in patients with colorectal cancer T1/T2, N(+)
Acronym
Usefulness of postoperative adjuvant chemotherapy in patients with colorectal cancer T1/T2, N(+)
Scientific Title
Usefulness of postoperative adjuvant chemotherapy in patients with colorectal cancer T1/T2, N(+)
Scientific Title:Acronym
Usefulness of postoperative adjuvant chemotherapy in patients with colorectal cancer T1/T2, N(+)
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
After curative resection of Stage III colorectal cancer, postoperative adjuvant chemotherapy is recommended to improve survival by preventing recurrence.
Within Stage III colorectal cancer, there is a mixture of different conditions with different risks of recurrence.
The 5-year disease-free survival rates for Stage IIIA, Stage IIIB, and Stage IIIC are considered to be approximately 90%, 75%, and 60%, respectively.
The benefit of adjuvant chemotherapy with oxaliplatin in Stage IIIB and Stage IIIC may far exceed that of oral anticancer agents or 5FU alone.
On the other hand, the usefulness of adjuvant chemotherapy in Stage IIIA, especially T1 and N(+) patients is not clear due to the high 5-year disease-free survival rate.
Focusing on stage IIIA, especially T1 and N(+) patients, we will statistically compare risk factors affecting 3-year RFS, 5-year OS, etc. in the three groups of surgery alone, 5FU alone, and oxaliplatin combination therapy, and generate evidence to support the guidelines.
Basic objectives2
Others
Basic objectives -Others
Focusing on stage IIIA, especially T1 and N(+) patients, we will statistically compare risk factors affecting 3-year RFS, 5-year OS, etc. in the three groups of surgery alone, 5FU alone, and oxaliplatin combination therapy, and generate evidence to support the guidelines.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
relapse-free survival
disease-free survival
Time-to-treatment-failure
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with T1 / T2 and N (+) among all enrolled clinical studies conducted by JFMC in the past (JFMC7 / JFMC15 / JFMC33 / JFMC35 / JFMC37 / JFMC38 / JFMC41)
Key exclusion criteria
-
Target sample size
621
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
overall survival
relapse-free survival
disease-free survival
Time-to-treatment-failure
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=R000053627
