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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000193
Receipt No. R000000265
Scientific Title Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)
Date of disclosure of the study information 2005/09/12
Last modified on 2014/06/24

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Basic information
Public title Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)
Acronym Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)
Scientific Title Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)
Scientific Title:Acronym Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)
Region
Japan

Condition
Condition Stage III colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Disease-free survival
Key secondary outcomes Overall survival, Rate of adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: 5FU+l-leucovorin
Interventions/Control_2 B: UFT+Leucovorin
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 1) Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
2) Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
3) Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
4) No synchronous colorectal cancer which invade muscularis propria or deeper.
5) Tumor resection with D2 or D3 lymph node dissection was performed.
6) Pathological determination of curability of tumor resection is cur A.
7) Age at registration is above 20 and below 75 years old.
8) ECOG Performance status is 0 or 1.
9) No prior chemotherapy or radiation therapy.
10) Intake of normal diet and oral drugs is possible.
11) Major organ function is preserved.
WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl
12) Adjuvant chemotherapy can be started within 9 weeks after surgery.
13) Witten informed consent is taken.
Key exclusion criteria 1) Active co-existing malignancy (synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
2) Severe postoperative complicatoins which do not resolve until registration.
3) There is following complicaion.
insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pactoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
4) Pregnant or breast-feeding woman.
5) Difficult to participate with the trial, having mentel disorder or psychiatric symptoms.
6) Judged to be inappropriate to register.
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Shimada, MD
Organization National Cancer Center Hospital
Division name Division of medical oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Shimada, MD
Organization JCOG0205 Coordinating Office
Division name Division of medical oncology, National Cancer Center Hospital
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00190515
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 札幌厚生病院(北海道)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院(茨城県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
防衛医科大学校(埼玉県)
自治医科大学大宮医療センター(埼玉県)
国立がんセンター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がんセンター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学(東京都)
国立国際医療センター(東京都)
慶応義塾大学病院(東京都)
東京医科歯科大学(東京都)
癌研究会附属病院(東京都)
社会保険中央総合病院(東京都)
横浜市立大学医学部(神奈川県)
神奈川県立がんセンター(神奈川県)
昭和大学横浜市北部病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
石川県立中央病院(石川県)
愛知県がんセンター(愛知県)
藤田保健衛生大学(愛知県)
大阪府立成人病センター(大阪府)
国立大阪病院(大阪府)
関西労災病院(兵庫県)
岡山済生会総合病院(岡山県)
社会保険広島市民病院(広島県)
国立病院四国がんセンター(愛媛県)
国立病院九州がんセンター(福岡県)
久留米大学医学部(福岡県)
久留米大学医療センター(福岡県)

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0959804914007242
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Main results already published
Date of protocol fixation
2003 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2003 Year 02 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2014 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000265

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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