UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of resection of primary colorectal caner and synchronous liver metastasis after S-1 + oxaliplatin (SOX) + Bevacizumab(Bmab) therapy and adjuvant S-1 chemotherapy
Title of the study (Brief title)	Study of resection of primary colorectal caner and synchronous liver metastasis after SOX + Bmab
Region	Japan

Condition
Condition	Colorectal cancer with synchronous liver metastasis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to examine the efficacy and safety of resection of primary colorectal cancer and synchronous liver metrastasis after S-1 + oxaliplatin + bevacizumab and adjuvant S-1 chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	Overall survival, Relapse-free survival, R0 rate of primary tumor, R0 rate of liver metastasis, Reoperation rate, Completion rate of S-1 + oxaliplatin + bevacizumab, Safety, Efficacy

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 Maneuver
Interventions/Control_1	S-1 is administered orally at 80mg/m2/day for 14 consecuitive days followed by a 7 day rest. L-OHP is given intravenously on days 1, at a dose of 130mg/m2/day.Bevacizumab is given intravenously on days 1, at a dose of 7.5mg/kg/day. 21 days are assumed 1 course, and chemotherapy consisted of 4 courses. Surgery is carried out in 8 to 12 weeks after the end of chemotherapy.
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) Histologically confirmed Rectum adenocarcinoma 2) Adequate following in the diagnostic imaging within 28 days before registration 1. Clinical stage T3, any N, or T4, any N 2. The edge of tumor is lower than Ra, Rb, P (Within 12cm from anal verge) 3. Unresectable rectal cancer by organ-sparing TME which was judged by high resolutoin MRI -CRM<=1mm -T4b -Lateral lymph node metastasis 3) Without liver, peritoneum and distant metastases 4)Age of 15-75 years 5)Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy) 6)Aadequate function of important organs 1. WBC: >=3,000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T Bil: <=2.0mg/dL 6. AST, ALT: <100IU/L 7. Serum creatinine: <=1.2mg.DL 8. Creatinin clearance level >= 60mi/min 9. Urine protein<=1+ 10. INR<=1.5 7) ECG: without clinically problematic abnormalities within 28 days before registration 8) Eastern Cooperative Oncology Group performance status (PS) 0-1 9) With ability of oral intake 10) Written informed concent "
Key exclusion criteria	"1) with gastrointestinal ulceration or bleeding 2) with sensory neuropathy 3) with severe diarrhea 4) had a previous serious drug allergies 5) had pleural effusion or ascites which need therapy 6) with brain metastasis or suspected the brain metastases 7) had surgery within 28 days before registration 8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia 9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 10) with active double cancer 11) had active infection disease (over 38.0 degree) 12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 13) receiving Flucytosine 14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 15) had hemoptysis (2.5 ml or more of fresh blood) 16) had gastrointestinal perforation within 6 months 17) were systemically-administered of steroids 18) with contraindications to TS-1, L-OHP, and Bevacizumab 19) with HBsAg-positive 20) Physician will determine that the patient is inappropriate participate in this trail for the safety. "
Target sample size	28

Research contact person
Name of lead principal investigator	Hajime Morohashi
Organization	Hirosaki University Graduate School of Medicine
Division name	Gstroenterological Surgery
Address	5 Zaifu-chou, Hirosaki, Aomori, Japan
TEL	0172-39-5079
Email	hm2002@hirosaki-u.ac.jp

Public contact
Name of contact person	Hajime Morohashi
Organization	Hirosaki University Graduate School of Medicine
Division name	Gstroenterological Surgery
Address	5 Zaifu-chou, Hirosaki, Aomori, Japan
TEL	0172-39-5079
Homepage URL
Email	hm2002@hirosaki-u.ac.jp

Sponsor
Institute	Aomori Colorectal Cancer Study (ACCS) group
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 14 Day
Anticipated trial start date	2018 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	2018 Year 04 Month 04 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036626