UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Title of the study (Brief title)	Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE III)
Region	Japan

Condition
Condition	Stage III colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the superiority of disease-free survival of aspirin to placebo as adjuvant therapy for stage III colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Disease-free survival
Key secondary outcomes	Overall survival, Relapse-free survival, Relative dose intensity, Adverse events, Sever adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
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	A:Placebo. Patients in this group receive placebo for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine).
Interventions/Control_2	B:Aspirin. Patients in this group receive aspirin, at a dose of 100 mg for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine).
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) Pathologically proven colorectal adenocarcinoma. 2) Tumor is mainly located between cecum and upper rectum, excluding appendix and that invades to lower rectum. 3) Tumor resection with D2 or D3 lymph node dissection was performed. 4) R0 resection was performed. 5) Stage III cancer (UICC TNM classification 7th ed.). 6) No synchronous colorectal cancer which invade muscularis propria or deeper. 7) Age at registration is of 20 to 80 years old. 8) ECOG Performance status is 0 or 1. 9) No prior chemotherapy or radiation therapy. 10) No anti-platelet drug or anti-coagulant drug at registration. 11) No periodic oral NSAIDs at registration. 12) No history or complication of gastric or duodenal ulcer 13) No history of bronchial asthma. 14) No inflammatory bowel disease and hemorrhagic disease. 15) It is possible to take foods and drugs orally. 16) Within 8 weeks after surgery. 17) Major organ function is preserved. ANC>=3,000/mcl, PLT>=75,000/mcl, T-bil<=2.0 mg/dl, GOT<=100 IU/L, GPT<=100 IU/L , Cr<=1.5 mg/dl 18) The following chemotherapy will be performed as adjuvant chemotherapy. 1.Cpecitabine,2.mFOLFOX6,3.CAPOX 19) Witten informed consent is obtained
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies 2) Infections which needs systemic treatment. 3) Body temperature is higher than 38 degrees centigrade at registration. 4) History of allergy aspirin or salicylic acid. 5) Female during pregnancy, within 28 days of postparturition, or during lactation. 6) Severe psychological disease. 7) Continuous systemic corticosteroid or immunosuppressant treatment. 8) Severe postoperative complicatoins which do not resolve until registration. 9) Regularly using phenytoin. 10) Uncontrollable diabetes mellitus. 11) Uncontrollable hypertension. 12) Unstable angina pectoris, or history of myocardial infarction within 6 months.
Target sample size	880

Research contact person
Name of lead principal investigator	Tetsuya Hamaguchi
Organization	Saitama medical university International medical center
Division name	Department of Gastroenterology
Address	1397-1, Yamane, Hidaka, Saitama, 350-1298, Japan
TEL	042-984-4111
Email	thamaguc@saitama-med.ac.jp

Public contact
Name of contact person	Atsuo Takashima
Organization	JCOG1503C Coordinating Office
Division name	Gastrointestinal Medical Oncology, National Cancer Center Hospital
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL	03-3542-2511
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	山形県立中央病院(山形県) 群馬県立がんセンター(群馬県) 防衛医科大学校(埼玉県) 埼玉県立がんセンター(埼玉県) 埼玉医科大学国際医療センター(埼玉県) 国立がん研究センター東病院(千葉県) 千葉県がんセンター(千葉県) 国立がん研究センター中央病院(東京都) 東京医科歯科大学(東京都) 東邦大学医療センター大橋病院(東京都) 神奈川県立病院機構神奈川県立がんセンター(神奈川県) 横浜市立大学附属市民総合医療センター(神奈川県) 新潟県立がんセンター新潟病院(新潟県) 静岡県立静岡がんセンター(静岡県) 愛知県がんセンター中央病院(愛知県) 大阪国際がんセンター(大阪府) 関西労災病院(兵庫県) 県立広島病院(広島県) 国立病院機構四国がんセンター(愛媛県) 高知医療センター(高知県)

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 23 Day
Anticipated trial start date	2018 Year 03 Month 30 Day
Last follow-up date	2028 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Advanced Medical Care B

Management information
Registered date	2018 Year 03 Month 01 Day
Last modified on	2018 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035650