UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.
Title of the study (Brief title)	Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.(KSCC1303)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of C-SOX as adjuvant chemotherapy for Stage III colon cancer.
Basic objectives2	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	The rate of completion of treatment as planned Adverse event Relative dose intensity Disease free survival Overall 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
Interventions/Control_1	Oxaliplatin 130 mg/m2 (day 1) S-1 80-120 mg/day (day1-14) to be repeated every 3 weeks.
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	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) Pathologically and Histologically confirmed colon adenocarcinoma 4) No prior chemotherapy and radiotherapy 5) Stage III, pathologically confirmed colon adenocarcinoma 6) R0 resection with D2 or D3 lymph node dissection was performed 7) Registration within 8 weeks after surgery 8) Age >= 20 years old 9) PS 0-1 10) Be able to take oral drugs 11) Recovery of postoperative complications 12) Required baseline laboratory parameters (within 14 days before registration): i) Neu >= 1,500/mm3 ii) Hb >= 9.0g/dL iii) Plt >= 100,000/mm3 iv) AST <= 100IU/L v) ALT <= 100IU/L vi) T-Bil < 2.0mg/dl vii) Ccr >= 60mL/min
Key exclusion criteria	1) History of the severe hypersensitivity 2) Active other malignancies 3) Sensory neuropathy >= Grade 1 4) Diarrhea >= Grade 2 5) Active infections 6) History of mental disorder, central nerve disorder 7) Serious complication 8) Blood transfusion or hemopoietic factors (e.g. G-CSF) within 14 days 9) Pleural effusion, peritoneal fluid that needs treatment 10) Hemorrhagic diathesis, coagulation disorder 11) Patients who need flucytosine, phenytoin or warfarin potassium 12) Requiring steroid drug 13) Pregnant or lactating woman and man who hope for Partner's pregnant 14) Positive for HBs antigen and HCV antibody 15) Investigator's judgement
Target sample size	85

Research contact person
Name of lead principal investigator	Shoji Natsugoe
Organization	Kagoshima University
Division name	Department of Digestive Surgery, Breast and Thyroid Surgery
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL	092-631-2920
Email	kscc2@cres-kyushu.or.jp

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	kscc2@cres-kyushu.or.jp

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

Funding Source
Organization	Yakulto Honsha Co.
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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 22 Day
Anticipated trial start date	2014 Year 02 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 18 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014438