UMIN-CTR Clinical Trial

Public title

Liver resection after chemotherapy for liver only metastasis from colorectal cancer

Acronym

Liver resection after chemotherapy for liver only metastasis from colorectal cancer

Scientific Title

Liver resection after chemotherapy for liver only metastasis from colorectal cancer

Scientific Title:Acronym

Liver resection after chemotherapy for liver only metastasis from colorectal cancer

Region

Japan

Condition

Liver metastasis of colorectal cancer

Classification by specialty

Gastroenterology

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study aims to evaluate the efficacy and safety of liver resection after chemotherapy with modified FOLFOX6 plus BV(bevacizumab) for colorectal cancer with liver-only metastasis (H2, H3).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Curative resection rate (R0 resection rate) [in all subjects]

Key secondary outcomes

1) Resection rate,
Curative resection rate (R0 resection rate) [in all resected subjects],
Conversion rate of nonresectable disease to resectable disease in subjects with nonresectable liver metastasis
Conversion rate of resectable disease to nonresectable disease in subjects with resectable liver metastasis
2) Safety of liver resection after chemotherapy with modified FOLFOX6 plus BV
3) Safety and efficacy of modified FOLFOX6 plus BV
4) Recurrence rate, Overall survival, Progression-free survival (in subjects with resectable liver metastasis), Relapse-free survival (in subjects with curative liver resection)

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

Chemotherapy with modified FOLFOX6 plus BV(bevacizumab).
Treatment repeats every 14 days for up to 6 courses (5 courses for BV) in the absence of disease progression or unacceptable toxicity.
Liver resection (if possible, 4 to 8 weeks after modified FOLFOX6 plus BV)

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Histopathologically confirmed adenocarcinoma of the colon and rectum

(2) Complete resection (R0 resection) of primary colorectal cancer more than 28 days prior to entry

(3) No extrahepatic metastasis or reccurrence

(4) The classsification of liver metastasis: H2 or H3

(5) No prior chemotherapy for colorectal cancer

(6) No prior ablation therapy or cryotherapy for liver metastasis

(7) ECOG performance status 0-1

(8) Age: 20 years to 80 years

(9) Life expectancy: at least 12 weeks

(10) Vital organ functions (listed below) are preserved within 2 weeks prior to entry
a) WBC: 4,000/mm3 to 12,000/mm3
b) Neutrophil: 1,500/mm3 and more
c) Platelet count: 100,000/mm3 and more
d) Total billilubin : 2.00mg/dL and under
e) AST and ALT: 100IU/L and under
f) Serum creatinine: 1.20mg/dL and under
g) PT(INR): less than 1.5
f) Urinary protein: grade1 (+1) and under

(11) Signed written informed consent

Key exclusion criteria

(1) Transfusion or blood product or growth factor such as G-CSF less than 7 days prior to entry

(2) Prior severe drug allergy

(3) Radiotherapy less than 4 weeks prior to entry

(4) Chronic daily treatment with anti-platelet drug such as high dose aspirin (more than 325mg/day) or other NSAID (temporary use of NSAIDs for cancer pain are permitted)

(5) Presence of cerebrovascular disease or symptoms less than 1 year prior to entry

(6) Presence of uncontrolled pleural effusion or ascites

(7) Presence of cardiac effusion

(8) Presence of active infection

(9) Presence of viral hepatitis

(10) Other active malignancy or multiple colorectal cancers

(11) Severe postoperative complications(e.g. postoperative infection, anastomotic dehiscence,or paralytic ileus)

(12) Uncontrolled co-mobility, such as hypertension, diabetes, arrhythmia, or other medical conditions

(13) Hemorrhage/bleeding,paralytic ileus, obstruction, or ulceration of gastrointestinal tract

(14) Perforation of gastrointestinal tract less than 1 year prior to entry

(15) Grade 2 diarrhea or sensory neuropathy

(16) Chronic systemic treatment of corticosteroid

(17) Phenytoin, Warfarin potassium, or flucytosin administration

(18) Surgery, biopsy with skin incision, or traumatic injury with suture less than 4 weeks prior to entry

(19) Nursing or pregnant females, or females or males with female partners who are planning to pregnancy

(20) Participation in other clinical trial

(21) Any other serious medical condition that would preclude study treatment

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Sugihara, M.D., PhD

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical & Dental University

Division name

Dept. of Surgical Oncology,

Zip code

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

03-5803-5261

Email

Name of contact person

1st name
Middle name
Last name	Hiroyuki Uetake, M.D., PhD

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical & Dental University

Division name

Dept. of Surgical Oncology,

Zip code

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

03-5803-5261

Homepage URL

http://www.ibri-kobe.org/

Email

h-uetake.srg2@tmd.ac.jp

Institute

Tokyo Medical & Dental University

Institute

Department

Personal name

Organization

Foundation for Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

2009

Year

06

Month

22

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

Date of protocol fixation

2009

Year

04

Month

15

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2013

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

06

Month

22

Day

Last modified on

2010

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002557