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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006750
Receipt No. R000007979
Scientific Title Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in Stage III colon cancer
Date of disclosure of the study information 2011/11/20
Last modified on 2011/11/20

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Basic information
Public title Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in Stage III colon cancer
Acronym N-SOG 08
Scientific Title Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in Stage III colon cancer
Scientific Title:Acronym N-SOG 08
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate feasible administration schedules for adjuvant therapy of TS-1 for stage III colon cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 3-year disease free survival rate
Key secondary outcomes Treatment completion rate, relative dose intensity, disease free survival, overall survival, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TS-1 is administered orally at a dose of 80 mg/m2/day b.i.d. for 28 days followed by 14 days of rest. Cycles are repeated every 6 weeks until 4 courses.
Interventions/Control_2 TS-1 is administered orally at a dose of 80 mg/m2/day b.i.d. for 14 days followed by 7 days of rest. Cycles are repeated every 3 weeks until 8 courses.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histological proven stage III colon cancer or rectosigmoid cancer
2) Histologically confirmed adenocarcinoma of colorectal cancer
3) Curability A
4) Age: >=20
5) Performance Statues: 0-1(ECOG)
6) Without prior treatment except surgery
7) With ability of oral intake
8) Sufficient function of important organs within 14 days before the registration
9) With starting the treatment within 8 weeks after operation
10) Written informed consent
Key exclusion criteria 1) Active double cancer
2) Synchronous or metachronous colorectal cancer
3) Severe postoperative complications
4) With following complications
a) Uncontrollable diabetes mellitus
b) Uncontrollable hypertension
c) Mycardial infraction within 6 months
d) Liver cirrhosis
e) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
5) Pregnant or nursing women, women who wish to become pregnant and men who are planning partners' pregnancy
6) History of mental disorder or treating it at the moment
7) Administration contraindication of TS-1
8) Continuous use of warfarin potassium
9) History of severe allergy
10) Not suitable for participation with any other reasons
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Nagino
Organization Nagoya University Graduated School of Medicine
Division name Division of Surgical Oncology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Uehara
Organization Nagoya University Graduated School of Medicine
Division name Division of Surgical Oncology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL 052-744-2222
Homepage URL
Email kuehara@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Surgical Oncology Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 20 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 20 Day
Last modified on
2011 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007979

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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