UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014492 |
|---|---|
| Receipt number | R000016856 |
| Scientific Title | A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis |
| Date of disclosure of the study information | 2014/07/07 |
| Last modified on | 2022/01/11 20:05:51 |
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Basic information
Public title
A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis
Acronym
A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis
Scientific Title
A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis
Scientific Title:Acronym
A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis
Region
| Japan |
Condition
Condition
Resectable colorectal cancer with hepatic metastasis
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the efficacy and safety of UFT/UZEL as adjuvant chemothrapy for resectable colorectal cancer with hepatic metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease Free Survival
Key secondary outcomes
Overall Survival, Relapse Free Survival, Safety, the ratio of the patients who completed the course of UFT/UZEL, Quality of Life
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Colorectal cancer is hitologically diagnosed
2. Synchronous or metachronous liver metastasis is diagnosed
3. There are no distant metastasis, recurrence except liver on CT within 4 weeks before liver resection
4. Curative resection (R0)is performed
5. The age is between 20 years old and 80 years old at the registration day.
6. Performance status is 0-2 cases.
7. The oral intake of the drug is possible.
8. A major organ function is maintained by a laboratory study within 14 days before registration.
9. An agreement is obtained in a document from the patients.
Key exclusion criteria
1. multiple primary cancer
2. Serious postoperative complications
3. Case with the following complications
-Poor control diabetes mellitus
-Poor control hypertention
-Myocardial infarction or unstable angina within six months.
-Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
4. Case with the following
-A pregnant woman or the women who may be pregnant or hope to be pregnant
-lactating women
5. The patients complicated with psychosis or neurologic manifestation, and judged to have difficulty in participation in clinical trials.
6. The case judged to be unsuitable for registration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
Address
N-15 W-7, Kita-ku, Sapporo, Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Yokoo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
Address
15 W-7, Kita-ku, Sapporo, Japan
TEL
011-706-5927
Homepage URL
hi-yokoo@mua.biglobe.ne.jp
Sponsor or person
Institute
Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016856
