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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000077
Receipt No. 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

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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
Email 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
Email hyamamoto@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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