UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Title of the study (Brief title)	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	Yoshito Akagi
Organization	Kurume university
Division name	Surgery
Address	67 Asahi-cho, Kurume city, 830-0011, Japan
TEL	092-631-2920
Email	sakamoto.kscc@gmail.com

Public contact
Name of contact person	KSCC
Organization	Clinical Research Support Center Kyushu
Division name	KSCC
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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)
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