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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011486
Receipt No. R000013441
Scientific Title Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Date of disclosure of the study information 2013/08/14
Last modified on 2019/03/01

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Basic information
Public title Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Acronym Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Scientific Title Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Scientific Title:Acronym Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer, and to identify the more promising regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 3-years Disease free survival rate
Key secondary outcomes Pathological Effect
R0 resection rate
Completion rate of each modality(Neoadjuvant chemotherapy, Operation and Adjuvant chemotherapy)
Overall survival(OS)
Disease Free survival(DFS)
OS in patients with R0 resection
DFS in patients with R0 resection
Transition rate to Operation
local recurrence rate(per Operated population)
Safety
Pattern of first recurrence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
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 S-1 80 mg/m2 p.o. (day1-14)
L-OHP 130 mg/m2(day 1)
to be repeated every 3 week until 4 course or to meet discontinuation criteria
Interventions/Control_2 5-FU/bolus 400mg/m2 (day 1),
5-FU/continuous2,400 mg/m2 (day 1-2),
every 2 week
to be repeated every 2 week until 6 course or to meet discontinuation criteria
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) Written informed consent
2) Patients who are judged to be suitable for receiving this protocol therapy by physician
3) Distal border of tumor is located under the peritoneal reflection
4)Histologically confirmed rectal adenocarcinoma
5) previously untreated rectal cancer
6) Within 28 days before registration, the tumor is considered by the surgeon to be amenable to curative resection [T category: cSS and cSE, cSI, cA, cAI. N category:cN0-2 and cN3(#253 lymph node)]
7) Within 28 days before registration, there is no evidence of distant metastasis by contrast-
enhanced CT
8) >= 20 years old
9) PS(ECOG) 0-1
10) be able to take oral drugs
11) Required baseline laboratory parameters (within 14 days before registration):
WBC >= 3000 ,<12000/mm3
Neu >= 1,500/ mm3
Hb >= 9.0g/dl
Plt >= 100,000/ mm3
T-Bil <= 2.0mg/dl
AST,ALT <= 100U/L
Cre <1.5mg/dl
Ccr >= 60mL/min
12) Considered to survive for more than 3 months.
Key exclusion criteria 1) History of serious drug hypersensitivity or a history of drug allergy
2) Pregnant or lactating woman and man who hope for Partner's pregnant
3) Active infection(over 38 degree)
4) Blood transfusion within 14 days before registration
5) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension)
6) Clinically significant abnormal electrocardiogram or heart disease
7) Serious diarrhea
8) Pleural effusion, peritoneal fluid that needs treatment
9) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
10) Hemorrhagic diathesis, coagulation disorder
11) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less).
12) Patients who need flucytosine, phenytoin or warfarin potassium.
13) Requiring steroid drug
14) Patients with contraindication to therapy
15) History of allergy to contrast material
16) Serious stricture (exclude the patients who are put in stoma)
17) Positive for HBs antigen and HCV antibody
18) Not appropriate for the study at the physician's assessment
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Akagi
Organization Kurume university
Division name Surgery
Zip code
Address 67 Asahi-cho, Kurume city, 830-0011, Japan
TEL 092-631-2920
Email sakamoto.kscc@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name KSCC
Organization Clinical Research Support Center Kyushu
Division name KSCC
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL 092-631-2920
Homepage URL
Email sakamoto.kscc@gmail.com

Sponsor
Institute Kyushu Study group of Clinical Cancer(KSCC)
Institute
Department

Funding Source
Organization Taiho Pharmaceutical co., LTD
Organization
Division
Category of Funding Organization Profit organization
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 宗像医師会病院(福岡県),田川市立病院(福岡県),防府消化器病センター防府胃腸病院(山口県),医理会柿添病院(長崎県),愛知県がんセンター愛知病院(愛知県),長崎大学 移植・消化器外科(長崎県),筑後市立病院(福岡県)佐世保市立総合病院(長崎県),岡山労災病院(岡山県),伊万里有田共立病院(佐賀県),神戸市立医療センター中央市民病院(兵庫県),兵庫県立がんセンター(兵庫県),県立広島病院(広島県),済生会福岡総合病院(福岡県),久留米大学(福岡県),国立病院機構九州医療センター(福岡県),兵庫医科大学(兵庫県),製鉄記念八幡病院(福岡県),長崎大学 腫瘍外科(長崎県),熊本大学(熊本県),鹿児島厚生連病院(鹿児島県),広島赤十字・原爆病院(広島県),人吉医療センター(熊本県),中津市立中津市民病院(大分県),獨協医科大学(栃木県),松山赤十字病院(愛媛県),社会保険田川病院(福岡県),国立病院機構大分医療センター(大分県),大分大学(大分県),久留米大学医療センター(福岡県),東京医科大学(東京都),九州大学(福岡県),九州大学別府病医療センター(大分県),東邦大学医療センター大森病院(東京都),大分県立病院(大分県),岐阜大学(岐阜県),熊本市立熊本市民病院(熊本県),金沢赤十字病院(石川県),国立病院機構九州がんセンター(福岡県),田主丸中央病院(福岡県),佐世保中央病院(長崎県),公立学校共済組合九州中央病院(福岡県),潤愛会鮫島病院(鹿児島県),飯塚病院(福岡県),高野会高野病院(熊本県),済生会熊本病院(熊本県),熊本地域医療センター(熊本県),社会保険仲原病院(福岡県),国立病院機構別府医療センター(大分県),鹿児島大学(鹿児島県),福岡市民病院(福岡県),北播磨総合医療センター(兵庫県),関西労災病院(兵庫県),名古屋大学(愛知県),聖マリアンナ医科大学(神奈川県),聖マリアンナ医科大学横横浜市西部病院(神奈川県),聖マリアンナ医科大学東横病院(神奈川県),済生会八幡総合病院(福岡県),久留米総合病院(福岡県),大分赤十字病院(大分県),済生会川内病院(鹿児島県),琉球大学(沖縄県),国立病院機構名古屋医療センター(愛知県),江南厚生病院(愛知県),岡崎市民病院(愛知県),薫風会佐野病院(兵庫県),小樽掖済会病院(北海道),群馬大学(群馬県),中頭病院(沖縄県),浦添総合病院(沖縄県), 済生会唐津病院(佐賀県),国立病院機構福岡東医療センター(福岡県),福井県済生会病院(福井県),神戸大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
ASCO 2017(2017/6/2~6CHICAGO,ILLINOIS in USA)
A Randomized PhaseII Study Evaluating Efficacy and Safety of SOX versus mFOLFOX6 
as Neoadjuvant Chemotherapy for Patients with Resectable Rectal cancer(KSCC1301)
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
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 10 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
2013 Year 08 Month 14 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013441

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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