UMIN-CTR Clinical Trial

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

Colorectal liver metastases

Classification by specialty

Gastrointestinal surgery

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Miyagi HBPCOG

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

10

Month

07

Day

Last modified on

2015

Year

04

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004184