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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004352
Receipt No. R000004184
Scientific Title Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases
Date of disclosure of the study information 2010/10/10
Last modified on 2015/04/07

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Basic information
Public title Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases
Acronym Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases
(Miyagi-HBPCOG 007)
Scientific Title Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases
Scientific Title:Acronym Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases
(Miyagi-HBPCOG 007)
Region
Japan

Condition
Condition Colorectal liver metastases
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of bevacizumab with XELOX as adjuvant chemotherapy after resection of colorectal liver metastases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes disease free survival
Key secondary outcomes Overall survival
2-year DFS rates
Relapse-free survival
Safety
Treatment continuation rate
5 courses
8 courses

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 After resection of colorectal liver metastases, chemotherapy with bevacizumab plus XELOX repeats every 3 weeks for 8 times.
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.Histologically confirmed colorectal carcinoma
2.Curative resection (sR0, sR1) for synchronous or metachronous liver metastases and primary tumour. No prior radiotherapy for liver metastases
3.No extrahepatic metastases or recurrence
4.Expect first administration within 4~8 weeks after liver resection (Enrollment is within 2~8 weeks after liver resection)
5.Age >=20 years
6.ECOG PS 0-1
7.Needs adequate organ function
8.Witten informed consent
Key exclusion criteria 1. Recurrence of chemotherapy of capecitabine, oxaliplatin and bevacizumab less than 6 months
2. Active multiple cancers (within 5 years)
3. Histry of hyper sensitivity against bevacizumab, oxaliplatin and capecitabine
4. Serious infections
5. Serious complications
6. Serious alteration or paresthesia interfering with function
7. Pregnancy woman, or woman with suspected pregnancy
8. Histry of organ recipient
9. Surgery, biopsy, specimen with section or sutures within the past 2 weeks. Fine needle aspiration biopsy within 1 week
10. Thrombosis with present or history of thromboembolism within the past 1 year
11. Administrated with Aspirin (>=325mg/day) or steroid for RA and chronic inflammatory disease
12. Untreatment of traumatic bone fracture
13. Require treatment of renal dysfunction, or urine protein >+2 within 2 weeks
14. Uncontrollable hypertension
15. Uncontrollable diarrhea
16. Uncontrollable peptic ulcer disease
17. Severe pulmonary disease (Interstitial pneumonitis or pulmonary fibrosis)
18. Cardiac disease (over grade2 by CTCAE v4.0).Or histry of myocardial infarction within 1 year
19. Doubting dihydropyrimidine dehydrogenase (DPD) deficit
20. Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Unno
Organization Tohoku University Graduate School of Medicine
Division name Division of Hepato-Biliary Pancreatic Surgery Department of Surgery
Zip code
Address 1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574 Japan
TEL 022-717-7205
Email kein_h11@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nakagawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Integrated Surgery and Oncology
Zip code
Address 1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574 Japan
TEL 022-717-7205
Homepage URL
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyagi HBPCOG
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
2010 Year 10 Month 10 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
2010 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 10 Month 07 Day
Last modified on
2015 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004184

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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