UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000077 |
|---|---|
| Receipt number | R000000126 |
| Scientific Title | Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS)for Predicting the Prognosis and Therapeutic Effects of Doxifluridine, An Intermediate form of Capecitabine, in adjuvant therapy for postoperative Node positive colorectal cancer(DukesC); Findings from a multicenter Phase2 trial. |
| Date of disclosure of the study information | 2006/01/01 |
| Last modified on | 2015/12/30 21:44:26 |
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Basic information
Public title
Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS)for Predicting the Prognosis and Therapeutic Effects of Doxifluridine, An Intermediate form of Capecitabine, in adjuvant therapy for postoperative Node positive colorectal cancer(DukesC); Findings from a multicenter Phase2 trial.
Acronym
Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS) in adjuvant therapy of Capecitabine for postoperative Node positive colorectal cancer(DukesC).
Scientific Title
Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS)for Predicting the Prognosis and Therapeutic Effects of Doxifluridine, An Intermediate form of Capecitabine, in adjuvant therapy for postoperative Node positive colorectal cancer(DukesC); Findings from a multicenter Phase2 trial.
Scientific Title:Acronym
Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS) in adjuvant therapy of Capecitabine for postoperative Node positive colorectal cancer(DukesC).
Region
| Japan |
Condition
Condition
Dukes'C colorectal cancer which is removed curatively and surgically
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the following points by measuring the level of TP,DPD and TS, and examining the localization.
1)The correlation of these factors and clinical pathology features
2)The correlations of these factors and prognosis effect of 5'-DFUR after the operation as adjuvant chemotherapy,
3)Examine the method of selecting the patient with high possibility that DFUR takes effect
and establish patient oriented chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
Overall survival
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
chemotherapy(Doxifluridine:5'-DFUR)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed adenocarcinoma
undergone radical operation and classified into Dukes'C
Performance status of 0, 1, or 2
Patient age is more than 20 and less than 75
Oral administration of 5'-DFUR is possible
Fresh specimens of colorectal cancer were obtained
No previous treatment except for resection
Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function
within six weeks after the operation
Written informed consent is required to obtain from each patient at each participating institution
Key exclusion criteria
appendiceal carcinoma and anal canal carcinoma of anal gland origin
Multiple cancer patients except m cancer
apparent infection
sever postoperative complications
active peptic ulcer
Cardiac infarction within three months-uncontrolled hypertension
-diabetes mellitus, uncontrolled or controlled with insulin
-unstable angina, myocardial infarction needed to treat or febrile neutropenia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morito Monden |
Organization
Osaka University Graduate School of Midicine
Division name
Department of Surgery And Clinical Oncology
Zip code
Address
2-2 Yamadaoka Suita-City Osaka
TEL
0668793251
hyamamoto@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Yamamoto |
Organization
Multicenter Clinical Study Group of Osaka,Colorectal Cancer Treatment Group
Division name
Coordinating Office
Zip code
Address
2-2 Yamadaoka Suita-City Osaka
TEL
06-6879-3251
Homepage URL
hyamamoto@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
Funding Source
Organization
Multicenter Clinical Study Group of Osaka
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
| 2006 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2001 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 24 | Day |
Last modified on
| 2015 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000126
