UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000385 |
|---|---|
| Receipt number | R000000475 |
| Scientific Title | A randomized controlled study comparing S-1 with UFT as postoperative adjuvant Chemotherapy in Rectal Cancer. |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2016/08/23 11:40:27 |
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Basic information
Public title
A randomized controlled study comparing S-1 with UFT as postoperative adjuvant Chemotherapy in Rectal Cancer.
Acronym
Adjuvant Chemotherapy Trial of TS-1 for Rectal Cancer (JFMC35-C1:ACTS-RC)
Scientific Title
A randomized controlled study comparing S-1 with UFT as postoperative adjuvant Chemotherapy in Rectal Cancer.
Scientific Title:Acronym
Adjuvant Chemotherapy Trial of TS-1 for Rectal Cancer (JFMC35-C1:ACTS-RC)
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness of S-1 comparing UFT as adjuvant chemotherapy for stage II / III rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Relapse - free survival (RFS)
Key secondary outcomes
Overall survival (OS), Adverse events
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
Group A (standard therapy group): UFT (400 mg/m2/day) is administered orally on days 1-5 of every week for 1 year.
Interventions/Control_2
Group B (trial therapy group): S-1 (80 mg/m2/day) is administered orally for 28 consecutive days repeated every 42 days for 1 year.
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) Histologically confirmed rectal adenocarcinoma (exclude Rs)
2) Histological Stage IIA, IIB, IIIA, IIIB, IIIC located
3) No synchronous colorectal cancer which invade submucosa or deeper
4) Curative resection with lymph node dissection
5) Resection of histological curability A was performed
6) No prior therapy
7) Within 42 days after the operation
8) Oral intake is possible
9) Sufficient organ functions
a. WBC >= 3,500/mm3
b. Hemoglobin >= 9g/dL
c. Platelet >= 100,000/mm3
d. Total bilirubin <= 1.2mg/dL
e. AST, ALT < 100IU/L
f. Serum creatinine <= 1.0mg/dL
10) Written informed consent
Key exclusion criteria
1) Anal gland derived cancer of anal canal
2) Active synchronous or metachronous malignancy other than carcinoma in situ
3) Serious postoperative complications
4) Serious coexisting illness
a. interstitial pneumonia, pulmonary fibrosis
b. intestinal paralysis or obstruction
c. uncontrolled diabetes mellitus
d. hepatic cirrhosis
e. hepatic failure
f. renal failure
g. uncontrolled hypertension
h. history of myocardial infarction, unstable angina within 6 months prior to the registration
5) Limitation of use of UFT or TS-1
6) Under treatment with flucytosine, phenytoin, or warfarin
7) Episode of drug allergy reaching grade 3 or more severe
8) Pregnant or nursing
9) Severe mental disorders
10) Positive HIV
11) Not suitable for participating in the study for any other reason
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
Address
TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL
03-5627-7594
Homepage URL
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2006 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1093/annonc/mdw162
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
| 2006 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000475
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