UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME
Acronym	Surgery after SOX+Bmab for unresectable rectal cancer by organ-preserved TME
Scientific Title	Phase II study of surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME
Scientific Title:Acronym	Surgery after SOX+Bmab for unresectable rectal cancer by organ-preserved TME
Region	Japan

Condition
Condition	Unresectable rectal cancer by organ-preserved TME
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 surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	T down-staging rate
Key secondary outcomes

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	18 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	32

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Miura
Organization	Hirosaki University Graduate School of Medicine
Division name	Gstroenterological Surgery
Zip code	036-8562
Address	5 Zaifu-chou, Hirosaki, Japan
TEL	0172395079
Email	tmiura@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Miura
Organization	Hirosaki University Graduate School of Medicine
Division name	Gstroenterological Surgery
Zip code	036-8562
Address	5 Zaifu-chou, Hirosaki, Japan
TEL	0172-39-5079
Homepage URL
Email	tmiura@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)

IRB Contact (For public release)
Organization	Hirosaki University Certified Review Board
Address	1 Bunkyo-cho Hirosaki, Aomori
Tel	0172-39-5295
Email	cksenta@hirosaki-u.ac.jp

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 03 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 14 Day
Date of IRB	2018 Year 02 Month 14 Day
Anticipated trial start date	2018 Year 03 Month 05 Day
Last follow-up date	2026 Year 03 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 07 Day
Last modified on	2019 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036106

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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