UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003272
Receipt number R000003940
Scientific Title Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)
Date of disclosure of the study information 2010/03/01
Last modified on 2022/08/30 16:45:47

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Basic information

Public title

Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)

Acronym

Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)

Scientific Title

Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)

Scientific Title:Acronym

Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS)

Region

Japan


Condition

Condition

Stage III colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the non-inferiority of disease-free survival of S-1 with capecitabine as adjuvant chemotherapy 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, Relapse-free survival, Adverse events (including treatment related death, early death, grade 4 non-hematological toxicities, grade 2 or more Hand-foot skin reaction).


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: capecitabine. Patients in this group receive 8 courses of oral capecitabine, at a dose of 1,250 mg/m2 twice daily for 14 days every 21 days.

Interventions/Control_2

B: S-1. Patients in this group receive 4 courses of oral S-1, at a dose of 40 mg/m2 twice daily for28 days every 42 days.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Pathologically proven colorectal adenocarcinoma.
2) Tumor is mainly located in between cecum and upper rectum, excluding appendix and that invades to lower rectum.
3) Tumor resection with D2 or D3 lymph node dissection was performed.
4) R0 resection was performed.
5) Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (same as UICC TNM classification 7th ed.).
6) No synchronous colorectal cancer which invade muscularis propria or deeper.
7) Age at registration is of 20 to 80 years old.
8) ECOG Performance status is 0 or 1.
9) No prior chemotherapy or radiation therapy.
10) It is possible to take foods and drugs orally.
11) Within 8 weeks after surgery.
12) Major organ function is preserved.WBC>=3,000/mcl, PLT>=75,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L , Cr<=1.5 mg/dl
13) Witten informed consent is taken

Key exclusion criteria

1) Body temperature is higher than 38 degrees centigrade at registration.
2) Infections which needs systemic treatment.
3) Active co-existing malignancy (synchronous or metachronous malignancy whose disease-free period is within 5 years). Carcinoma in situ is eligible.
4) Severe postoperative complicatoins which do not resolve until registration.
5) Regularly using phenytoin or warfarin potassium.
6) Pregnant or breast-feeding woman.
7) Difficult to participate in the trial due to mentel disorder or psychiatric symptoms.
8) Systemic steroids medication.
9) Uncontrollable diabetes mellitus.
10) Uncontrollable hypertension.
11) History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.

Target sample size

1550


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro Shimada

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

03-3542-2511

Email

JCOG_sir@ml.jcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetuya Hamaguchi

Organization

JCOG0910 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

03-3542-2511

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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

札幌厚生病院(北海道)
岩手医科大学(岩手県)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
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)
埼玉県立がんセンター(埼玉県)
自治医科大学附属さいたま医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
順天堂浦安病院(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学(東京都)
東邦大学医療センター大橋病院(東京都)
北里大学東病院(神奈川県)
神奈川県立病院機構(神奈川県)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
北里大学医学部(神奈川県)
昭和大学横浜市北部病院(神奈川県)
横浜市立大学附属市民総合医療センター(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)
長野市民病院(長野県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
藤田保健衛生大学(愛知県)
国立病院機構京都医療センター(京都府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
市立堺病院(大阪府)
箕面市立病院(大阪府)
市立吹田市民病院(大阪府)
関西労災病院(兵庫県)
兵庫医科大学(兵庫県)
岡山済生会総合病院(岡山県)
広島大学病院(広島県)
広島市立広島市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
久留米大学医学部(福岡県)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)


Other administrative information

Date of disclosure of the study information

2010 Year 03 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

Completed

Date of protocol fixation

2010 Year 02 Month 03 Day

Date of IRB

2010 Year 02 Month 19 Day

Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 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

2010 Year 03 Month 01 Day

Last modified on

2022 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003940


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name