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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032102
Receipt No. R000036626
Scientific Title 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
Date of disclosure of the study information 2018/04/04
Last modified on 2018/04/04

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Basic information
Public title 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
Acronym Study of resection of primary colorectal caner and synchronous liver metastasis after SOX + Bmab
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Hajime Morohashi
Organization Hirosaki University Graduate School of Medicine
Division name Gstroenterological Surgery
Zip code
Address 5 Zaifu-chou, Hirosaki, Aomori, Japan
TEL 0172-39-5079
Email hm2002@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Morohashi
Organization Hirosaki University Graduate School of Medicine
Division name Gstroenterological Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
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

Other
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

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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