UMIN-CTR Clinical Trial

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

Stage III colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Disease-free survival

Key secondary outcomes

Overall survival, Rate of adverse event

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2005

Year

09

Month

12

Day

URL releasing protocol

Publication of results

Published

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

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 related 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