UMIN-CTR Clinical Trial

Public title

Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer

Acronym

Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer

Scientific Title

Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer

Scientific Title:Acronym

Phase II trial of adjuvant mFOLFOX6 after metastasectomy for lung metastasis of colorectal cancer

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of mFOLFOX6 as the adjuvant chemotherapy after curative resection of lung metastases from colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

5-year survival rate

Key secondary outcomes

DFS, Safety, Site of relapse

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

Fluororacil/l-leucovorin plus oxaliplatin (mFOLFOX6)

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Potentially curative R0 resection was performed for patients with lung metastases from colorectal cancer.
2) Initial lung metastasectomy.
3) Pathological findings should be as follows
i)Histologically proven adenocarcinoma
ii)Less than 4 metastases.
iii)No pulmonary, hilar and mediastinal lymph node metastases.
4) Within 70 days after lung metastasectomy
5) No prior chemotherapy for advanced or metastatic disease.
i)Adjuvant chemotherapy with only FU is allowed.
ii)More than 180 days after the last chemotherapy .
6) No recurrence on chest and abdominal CT or MRI within 4 weeks before enrollment.
7) Age 20-75 years
8) ECOG performance status 0-1
9) Vital organ functions (listed below) are preserved within 1 week prior to entry.
i)White blood cell count >= 3,000/mm3 and <= 12,000/mm3
ii) Platelets>=100,000/mm3
iii)Hemoglobin> =9.0g/dl
iv)Total bilirbin> =1.5mg/dl
v)AST and ALT<= 100IU/l
vi)serum creatinine <= 1.5mg/dl
10) Written informed consent

Key exclusion criteria

1)Adjuvant FU was terminated because of ADR.
2)Multiple cancer patient (within 5 years)
3)Transfusion or blood product or growth factor such as G-CSF less than 14 days prior to entry.
4)Have following severe complications.
i)Bowel obstruction
ii)Uncontrolable heart disease
iii)Severe pulmonary fibrosis, interstitial lung disease, COPD
iv)Uncontrolable hypertension
v)Uncontrolable diabetes
vi)Active peptic ulcer
vii)Uncontrolable diarrhea
viii)bleeding diathesis
ix)HIV infection
x)Active infectious disease
5)Systemic and continuous steroids medication.
6)Severe peripheral neuropathy.
7)History of the serious hypersensitivity for drugs
8)Hepatitis B virus infection
9)Clinically significant mental or psychological disease.
10)Not pregnant
11)Patient who is taking flucytosine, phenytoin or warfarin potassium continuously.
12)Other conditions not suitable for this study.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Nozumu Machida

Organization

Shizuoka cancer center

Division name

Division of gastrointestinal oncology

Zip code

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, JAPAN

TEL

055-989-5222

Email

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

Address

NambaPlaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN

TEL

06-6633-7400

Homepage URL

Email

datacenter@wjog.jp

Institute

West Japan 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

2011

Year

06

Month

01

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

Completed

Date of protocol fixation

2011

Year

03

Month

28

Day

Date of IRB

2011

Year

06

Month

14

Day

Anticipated trial start date

2011

Year

07

Month

11

Day

Last follow-up date

2019

Year

07

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

06

Month

01

Day

Last modified on

2023

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006735