UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000193
Receipt number 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 14:51:53

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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 or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000265