UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006750 |
|---|---|
| Receipt number | 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 13:42:58 |
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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
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
kuehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Surgical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007979
