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

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 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


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

Value
https://center6.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