UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer
Title of the study (Brief title)	FACOS
Region	Japan

Condition
Condition	Colon cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of mFOLFOX6/XELOX regimen for patients with curatively resected stage III colon cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	3-year disease-free survival
Key secondary outcomes	Safety 2-year disease-free survival 5-year median survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Gene
Interventions/Control_1	mFOLFOX6(L-OHP:85mg/m2, l-LV:200mg/m2, 5FU:400mg/m2 (bolus), 5FU:2,400mg/m2 (civ)). Cycles of chemotherapy are given every 2 weeks for 6 months. XELOX(Capecitabine:2000mg/m2,Oxaliplatin:130mg/m2). Cycles of chemotherapy are given every 2 weeks for 6 months.
Interventions/Control_2
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Stage III colon and rectosigmoid cancer. 2.Colectomy with D2<= Lymph node dissection. 3.Resection of histological curability A was performed. 4.20-75 years old. 5.Performance Status(ECOG):0 or 1 6.Without prior anti-tumor therapy (chemotherapy and radiotherapy). 7.Adequate functions of bone marrow, liver and renal as belowes: WBC>= 4,000/mm3 to =<12,000mm3. Neutrophil >= 2,000/m m3. Platlet is >= 100,000/m m3. Hemoglobin >= 9.0g/dL. AST and ALT =< 100IU/L. Creatinine is within normal limits. 8.Able to start therapy between 4 and 8 weeks after surgery. 9.Written Informed Consent.
Key exclusion criteria	1.Synchronous multiple cancer and metachronous multiple cancer within 5-years. 2.Severe postoperative complications ,such as infection, ruptured suture, gastrointestinal bleeding. 3.Sensory peripheral neuropathy. 4.Uncontrolled hypertension. 5.Uncontrolled Diabetes Mellitus. 6.Marked abnormality of ECG, or clinically important cardiac disorders such as congestive heart failure, symptomatic coronary artery disease, uncontrolled arrythmia,history of cardiac infarction within 12 months. 7.Severe pulmonary complications, such as interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema. 8.With Evidence or history of psychiatric disability and central neurological disorder. 9.Diarrhea. 10.Systemic continuous administration of steroid drugs(p.o. or i.v.). 11.Pregnant, woman of child-bearing potential or lactating woman. 12.Not appropriate for the study at the physician's assessment.
Target sample size	130

Research contact person
Name of lead principal investigator	Hideyuki Ishida
Organization	Saitama Medical Center,Saitama Medical University
Division name	Department of digestive tract and
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	048-228-3619
Email	05hishi@saitama-med.ac.jp

Public contact
Name of contact person	Satomi Oyama
Organization	Saitama Medical Center,Saitama Medical University
Division name	Department of digestive tract and
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	048-228-3619
Homepage URL
Email	05hishi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center,Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center,Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
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	・埼玉医科大学総合医療センター（埼玉県） ・東松山医師会病院（埼玉県） ・福島県立医科大学病院（福島県） ・獨協医科大学病院（栃木県） ・東京女子医科大学東医療センター（東京都） ・高砂協立病院（東京都） ・帝京大学ちば総合医療センター（千葉県） ・松田病院（静岡県） ・金沢赤十字病院（石川県） ・順天堂大学医学部附属静岡病院（静岡県） ・千葉労災病院（千葉） ・高知大学医学部附属病院がん治療センター（高知） ・東邦大学医療センター佐倉病院（千葉） ・日本医科大学付属病院（東京都） ・友愛記念病院（茨城） ・獨協医科大学越谷病院（埼玉） ・上尾中央総合病院（埼玉）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 04 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 04 Month 12 Day
Last modified on	2017 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005434