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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013825
Receipt No. 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 2020/11/02

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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
Email 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
Email nabe-jun@comet.ocn.ne.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

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
Email 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
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016135

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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