UMIN-CTR Clinical Trial

Public title

PhaseII trial of neoadjuvant chemotherapy with TS-1, Oxaliplatin and Bevacizumab for resectable liver metastases from colorectal cancer

Acronym

N-SOG 05

Scientific Title

PhaseII trial of neoadjuvant chemotherapy with TS-1, Oxaliplatin and Bevacizumab for resectable liver metastases from colorectal cancer

Scientific Title:Acronym

N-SOG 05

Region

Japan

Condition

Resectable colorectal liver metastases

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of neoadjuvant chemotherapy with SOX plus Bevacizumab for resectable liver metastases from colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

R0 resection rate

Key secondary outcomes

PFS, Responce rate, adverse event rate, Relative dose intensity (RDI)

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

Neoadjuvant chemotherapy with SOX plus Bevacizumab followed by surgery

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

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Histopathologically confirmed adenocarcinoma of colorectal cancer
2)Resectable liver metastases from colorectal cancer except extrahepatic metastases
3)Age:20-79 years at registration
4)Confirmed liver metastases by chest,abdominal and pelvic CT and EOB-MRI, and no extrahepatic metastases
5)Performance status(PS)0-1
6)Without prior chemotherapy (including hepatic artery infusion) or RFA for liver metastases
7)Oral intake is possible
8)Adequate organ function (within 14 days before chemotherapy):
9)Alife expectancy greater than 3 months
10)Written informed consent

Key exclusion criteria

1) Active double cancer
2) Active infection
3) Fever of >= 38 degrees Celsius
4) Pregnant or nursing females. Males who are planning partners' pregnancy.
5)Severe mental disorder
6)Systemic administration of corticosteroids
7)Serious complications
8)Abnormal in electrocardiogram within 28 days before chemotherapy or clinically significant heart disease
9)Neuropathy
10)Uncontrolled diarrhea
11)Massive pleural or abdominal effusion
12)Brain metastases
13)History of thromboembolism, cerebral infarction, pulmonary infraction or interstitial pneumonia
14)Surgery within 28 days before chemotherapy
15)History of hypersensitivity for Oxaliplatin
16)History of hypersensitivity for TS-1
17)History of hypersensitivity for Bevacizumab
18)Under treatment with fluoropyrimidine except TS-1
19)Under treatment with flucytosine
20)Pretreatment with TS-1, Oxaliplatin or Bevacizumab
21)High grade stenosis at the primary tumor
22)Massive peritoneum dissemination
23)Bleeding (Congenital hemorrhagic disease) or coagulation disorder
24)Under treatment with anticoagulant
25)History of gastrointestinal perforation within 6 months before registration
26)History of hemoptysis
27)Not suitable for participation with any other reasons

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Masato Nagino

Organization

Nagoya University Graduated School of Medicine

Division name

Division of Surgical Oncology

Zip code

Address

65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan

TEL

052-744-2222

Email

Name of contact person

1st name
Middle name
Last name	Keisuke Uehara

Organization

Nagoya University Graduated School of Medicine

Division name

Division of Surgical Oncology

Zip code

Address

65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan

TEL

052-744-2222

Homepage URL

Email

kuehara@med.nagoya-u.ac.jp

Institute

Nagoya Surgical Oncology Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

12

Month

13

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

Enrolling by invitation

Date of protocol fixation

2010

Year

09

Month

09

Day

Date of IRB

Anticipated trial start date

2010

Year

12

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

12

Month

11

Day

Last modified on

2011

Year

10

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005590