UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013825 |
|---|---|
| Receipt number | R000016135 |
| Scientific Title | Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer |
| Date of disclosure of the study information | 2014/04/28 |
| Last modified on | 2022/03/16 13:24:16 |
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Basic information
Public title
Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer
Acronym
Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer(SOAP trial)
Scientific Title
Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer
Scientific Title:Acronym
Expiratory randomized phase II trial for optimizing treatment dose and duration of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer(SOAP trial)
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The subject of this randomised phase II trial is to determine optimal dose and treatment dulation of adjuvant S-1 plus oxaliplatin in patients with stage III colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease free survival
Key secondary outcomes
1)Relative Dose Intensity
2)completion rate
3)Relapse free survival
4)Overall survival
5)time-dependent change of peripheral neuropathy
6)Adverse event rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
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
arm A: L-OHP 100mg/m2, 8 courses (24 weeks)
1) 2 hour bolus infusion of 100mg/m2 of L-OHP on day1
2)According to BSA, from 80mg to 120mg of S-1 is taken divided twice a day from day 1 to day 15.
3) Period of one course is 21 days, 8 courses(24 weeks) is performed.
Interventions/Control_2
arm B: L-OHP 130mg/m2, 4 courses (12 weeks)
1) 2 hour bolus infusion of 130mg/m2 of L-OHP on day1
2)According to BSA, from 80mg to 120mg of S-1 is taken divided twice a day from day 1 to day 15.
3) Period of one course is 21 days, 4 courses(12 weeks) is performed
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) clinical stage II, III
2) tumor location is from cecum to rectosigmoid.
3) aged between 20 and 80 years old
4) ECOG Performance status of 0 or 1
5) no prior chemotherapy or radiotherapy
6) oral intake is possible
7) adequate bone marrow function with absolute neutrophil count >=1,500/microl, platelet count >=100,000/microl, adequate liver function with total bilirubin =<2 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) =<100IU/L, adequate renal function with Ccr >= 60ml/min
8) Able to start protocol treatment within 8 weeks of surgical procedure.
8) willing to provide written informed consent.
Key exclusion criteria
1) Tumor located below the peritoneum.
2) history of another malignancy within 5 years
3) Severe postoperattive complication (such as severe infection, severe anastomoitc leakage, intestinal bleeding)
4) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure.
5) Severe sensory disorder
6) Severe diarrhea
7) history of severe drug hypersensitivity
8) administration of flucytosine
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy
10) Severe psychiatric disorder
11) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenerological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
nabe-jun@comet.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenerological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
nabe-jun@comet.ocn.ne.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO.
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
Tel
045-370-7629
nextjim1@yokohama-cu.ac.jp
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
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立大学附属病院（神奈川県）
横須賀共済病院（神奈川県）
横浜市立市民病院（神奈川県）
藤沢市民病院（神奈川県）
済生会横浜市南部病院（神奈川県）
独立行政法人国立病院機構横浜医療センター（神奈川県）
横浜みなと赤十字病院（神奈川県）
横浜保土ヶ谷中央病院（神奈川県）
横須賀市立市民病院（神奈川県）
伊東市民病院（神奈川県）
NTT東日本関東病院（神奈川県）
済生会若草病院（神奈川県）
横浜掖済会病院（神奈川県）
長津田厚生総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 28 | 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
163
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
| 2014 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016135
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