UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer
Title of the study (Brief title)	Trial of Adjuvant Chemotherapy with PSK / UFT / LV
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy and safety of PSK/UFT/LV 6M and 12M as compared to UFT/LV 6M for an adjuvant therapy in patients with stage II/III colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	3 year desease free survival rate
Key secondary outcomes	Survival time Adverse event rate Completion rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A (standard therapy group:UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs.
Interventions/Control_2	Group B (trial therapy group: PSK/UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 6 months.
Interventions/Control_3	Group C (trial therapy group: PSK/UFT/LV 12M): Administration of 10 courses (12 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 12 months.
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.Histologically proven colorectal cancer. 2.StageII high risk/III colon cancer(C, A, T, D, S), rectal cancer(RS, Ra). 3.Curability A 4.Age between 20 and 80 years. 5.No prior chemotherapy or radiation. 6.Patients who could measure preoperative lymphocyte ratio. 7.Performance status of 0-1. 8.Patients who have satisfied the following the clinical test values within two weeks before the registration. 1)WBC:>= 3,000/mm3, <12,000/mm3 2)Neutrophile:>= 1,500/mm3 3)Hemoglobin:>= 9.0g/dL 4)Platelet:>= 100,000/mm3 5)AST(GOT),ALT(GPT): = <100IU/L 6)Total bilirubin: = < 2.0 mg/dL 7)Serum creatinine: =<1.5mg/dL 9.Patient with starting the treatment within 8 weeks after operation. 10.Written informed consent.
Key exclusion criteria	1.Synchronous or metachronous colorectal cancer. 2.Severe infectious disease. 3.Severe postoperative complications. 4.Patients with following complications. 1)Uncontrolled diabetes or hyperpiesia. 2)Myocardial infarction within the past 6 months or unstable angina pectoris. 3)Hepatic cirrhosis , interstitial pneumonia , lung fibrosis, advanced pneumonectasia 5.Patients with diarrhea more than 3 times/day. 6.Active synchronous or metachronous malignancy carcinoma in situ. 7.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period 8.Not suitable for participating in the study for any other reason.
Target sample size	200

Research contact person
Name of lead principal investigator	Izumi TAKEYOSHI
Organization	Gunma University Graduate School of Medicine
Division name	Department of Thoracic and Visceral Organ Surgery
Address	3-39-22 Showa-Machi, Maebashi, Gunma, 371-8511, JAPAN
TEL	027-220-8245
Email	takeyoshi@gunma-u.ac.jp

Public contact
Name of contact person	Hiroomi OGAWA
Organization	Gunma University Graduate School of Medicine
Division name	Department of Thoracic and Visceral Organ Surgery
Address	3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL	027-220-8245
Homepage URL
Email	hiroomio@gmail.com

Sponsor
Institute	Gunma University Graduate School of Medicine Department of Thoracic and Visceral Organ Surgery
Institute
Department

Funding Source
Organization	None
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	群馬大学医学部附属病院(群馬県)他

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 09 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 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

Management information
Registered date	2011 Year 04 Month 22 Day
Last modified on	2018 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006501