UMIN-CTR Clinical Trial

Public title

Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer

Acronym

Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer (CR study in SHIGA)

Scientific Title

Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer

Scientific Title:Acronym

Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer (CR study in SHIGA)

Region

Japan

Condition

Rectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of the effectiveness and safety of the cetuximab+mFOLFOX6 combination therapy as the primary treatment for KRAS wildtype advanced rectal cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Adverse effect (AE)
Progression free survival (PFS)
Disease control rate (DCR)
R0 resection rate
Rate of surgery
Time to Surgery (TTS)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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) Histologically confirmed colorectal cancer
(2) Previously receive no chemotherapy for rectal cancer
(3) KRAS wild-type
(4) age 20-80 years patients
(5) ECOG performance status 0 or 1
(6) Patients with confirmed target lesion
(7) Patients have enough organ function for study treatment
WBC 3,000/mm3-12,000/mm3
Neutrophils>=1,500/mm3
Platelets>=100,000/mm3
Hemoglobin>=9.0g/dL
Total bilirubin<=1.5mg/dL
AST and ALT<=100 IU/L
Creatinine<=1.2mg/dL
Creatinine Clearance>=60mL/min
(8) Life expectancy of more than 3months
(9) Written informed consent from patients themselves

Key exclusion criteria

(1) History of serious drug hypersensitivity
(2) Women who are pregnant,or wish to become pregnant or men who expect babies
(3) Severe infectious disease (38degrees or higher)
(4) Serious complications
(5) Remarkably abnormal ECG,Clinically significant heart disease
(6) Gastrointestinal ulceration or bleeding
(7) Serious watery diarrhea
(8) Uncontrolable pleural effusion or ascites requiring treatment
(9) Cases with brain metastases or cases to doubt metastasis to brain from clinical manifestations
(10) Current or previous (within the last 6months) history of GI perforation
(11) Previous history of thrombosis,cerebra infarction,pulmonary infarction,hemoptysis (more than 2.5ml) and interstitial pneumonia
(12) Cases were operated within 28days before entry (Except for inserting central venous catheters and reservoir)
(13) Evidence of congenital bleeding diathesis or coagulopathy
(14) Ongoing treatment with anticoagulant
(15) Cases have active double cancer (disease free period is within five years)
(16) Continuous systemic administration of corticosteroids
(17) Patients judged inapproprite for this study by physicians

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Eiji Mekata

Organization

Shiga University of Medical Science

Division name

Department of surgery

Zip code

Address

Seta Tsukinowa-cho,Otsu-city,Shiga,Japan

TEL

077-548-2238

Email

hqchemo@belle.shiga-med.ac.jp

Name of contact person

1st name
Middle name
Last name	EIJI Mekata

Organization

Shiga University of Medical Science

Division name

Department of surgery

Zip code

Address

Seta Tsukinowa-cho,Otsu-city,Shiga,Japan

TEL

077-548-2238

Homepage URL

Email

hqchemo@belle.shiga-med.ac.jp

Institute

NPO FMPC (Future Medicine Promoting Consortium)

Institute

Department

Personal name

Organization

NPO FMPC (Future Medicine Promoting Consortium)

Organization

Division

Category of Funding Organization

Other

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

2013

Year

05

Month

23

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

2012

Year

12

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

observational study

Registered date

2013

Year

05

Month

23

Day

Last modified on

2014

Year

05

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012440