UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011899 |
|---|---|
| Receipt number | R000013902 |
| Scientific Title | Feasibility study of UFT/LV as adjuvant chemotherapy for stage III colorectal cancer in elderly patients (over 80 years old) |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2024/10/05 13:06:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study of UFT/LV as adjuvant chemotherapy for stage III colorectal cancer in elderly patients (over 80 years old)
Acronym
Feasibility study of adjuvant chemotherapy for colorectal cancer in elder patients
Scientific Title
Feasibility study of UFT/LV as adjuvant chemotherapy for stage III colorectal cancer in elderly patients (over 80 years old)
Scientific Title:Acronym
Feasibility study of adjuvant chemotherapy for colorectal cancer in elder patients
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assses the feasibility of UFT/LV as adjuvant chemotherapy for stage III colorectal cancer in elderly patients (over 80 years old).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Safety, Overall survival, Disease free survival, Relative Dose Intensity
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
UFT+UZEL
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Clorectal cancer patients (Histologically confirmed)
2.Stage III colorectal cancer patients
3.patients who underwent R0 resection
4.ECOG Performance status: 0-2
5.80 years old or more
6.No previous history of chemotherapy or radiotherapy for colorectal cancer
7. Within 8 weeks after operation
8.Adequate organ functions
9.Oral food intake possible
10.Written informed consent
Key exclusion criteria
1.History of serious drug hypersensitivity
2.Wattery diarrhea
3.Cases with severe postoperative complication
4.Males with female partners who are planning to pregnancy
5.Severe comorbidity
6.Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
7.Any other serious or uncontrolled condition which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikeda Satoshi |
Organization
Hiroshima Prefectural Hospital
Division name
Surgery
Zip code
Address
1-5-54 Ujina-Kanda, Minami-ku, Hiroshima, 734-8530, JAPAN
TEL
082-254-1818
sikeda1965@way.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hinoi Takao |
Organization
Hiroshima University Hospital
Division name
Dept, of Gastroenterological and transplant surgery
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5222
Homepage URL
thinoi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Study group of Clinical Oncology (HiSCO)
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00280-023-04526-7
Number of participants that the trial has enrolled
69
Results
The indications for adjuvant UFT/LV therapy for elderly CRC aged 80 years or more were considered limited. It is necessary to clarify the background of patients in whom drug administration is discontinued and investigate their impact on long-term prognosis.
Results date posted
| 2024 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013902
