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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003272
Receipt No. 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 2013/08/26

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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
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 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 No longer recruiting
Date of protocol fixation
2010 Year 02 Month 03 Day
Date of IRB
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
2013 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.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


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