UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012442
Receipt number R000014528
Scientific Title Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumab
Date of disclosure of the study information 2013/11/29
Last modified on 2023/01/10 09:47:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumab

Acronym

Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6+bevacizumab or XELOX+bevacizumab

Scientific Title

Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumab

Scientific Title:Acronym

Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6+bevacizumab or XELOX+bevacizumab

Region

Japan


Condition

Condition

Advanced colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the correlation between the efficacy (PFS) and the biomarker in treated with mFOLFOX6+bevacizumab or XELOX+bevacizumab as first-line treatment of patients with advanced colorectal cancer

Basic objectives2

Others

Basic objectives -Others

Correlation between biomarkers and progression free survival

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Correlation between plasma VEGF-A level and Progression free survival time in CRC patients

Key secondary outcomes

1) Correlation between plasma VEGF-A level and overall survival time in CRC patients
2) Correlation between plasma VEGF-A level and response rate to the chemotherapy in CRC patients
3) Searching predictive/prognostic biomarkers other than VEGF-A in CRC patients
4) OS, PFS, ORR and the safety of Fluorouracil+Oxaliplatin+Bevacizumab chemotherapy in CRC patients


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

mFOLFOX6 + Bevacizumab or
XELOX + Bevacizumab

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histopathologically confirmed colorectal adenocarcinoma which is
a) Metastatic or locally advanced unresectable CRC with no prior therapy
b) Recurrence after resection of the primary and/or metastatic lesion and not a candidate for re-resection, and;
i) with no prior therapy other than surgery
ii) with post-operative adjuvant chemotherapy in the following conditions;
1)Relapsed at 180 day or after from the last administration of FU (w/wo LV)
2)Relapsed at 366 days or after from the last administration of Oxaliplatin
3) Only use of FU (w/wo LV) and/or Oxaliplatin are permitted as post-operative adjuvant chemotherapy
2. ECOG PS of 0 or 1.
3.Have evaluable lesions;
Following lesions are considered as not evaluable; Malignant effusion, bone metastasis, pulmonary lymphangites, abdominal masses that is not measurable by reproducible imaging and cystic lesions
4. Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters.
a) WBC count>=3000/mm3 and <=12000mm3
b) Platelet count>=100000/mm3
c) Hemoglobin level>=9g/dl
d) Total bilirubin<=1.5mg/dl
e) AST and ALT<=100IU/L (or AST,ALT<=200IU/L with liver metastases)
f) Serum creatinine<=1.5mg/dL
g) INR<1.5
h) Urine dipstick 1+ or less
5. Expected survival>= 90 days
6. Written informed consent obtained from the patient

Key exclusion criteria

1. Brain metastasis with symptoms.
2. Massive ascites, pleural effusion or pericardial effusions that need medical treatment.
3. Active another malignancies
4. Non-healing wound (excluding central venous port)
5. Major surgical procedure within 28 days prior to enroll in this study. (Minor surgical procedure within 14 days prior to enroll in this study.)
6. Other serious concomitant disease.
a) intestinal obstruction
b) History of arterial thromboembolic events such as unstable angina, myocardial infarction, and cerebrovascular accidents within 6 months.
c) Clinically significant cardiovascular disease
d) Severe pulmonary fibrosis, interstitial pneumonia or COPD on chest XP
e) Uncontrollable hypertension
f) Uncontrollable diabetes mellitus
g) Active peptic ulcer
h) Uncontrollable diarrhea
i) Hemorrhagic Diathesis
j) HIV infection
7. Regular use of corticosteroid.
8. Peripheral neuropathy>=Grade 1 at baseline.
9. Active local or systemic infectious disease.
10. History of serious hypersensitivity.
11. Blood tests positive for HBs antigen.
12. Uncontrollable severe mental disorder.
13. Pregnant or lactating female.
14. Judged inappropriate by the investigators

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Wataru Okamoto

Organization

National Cancer Center

Division name

Division of Translational Research, Exploratory Oncology Research & Clinical Trial Center

Zip code


Address

6-5-1 Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Email

wokamoto@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address

Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

6-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

CHUGAI PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

WJOG消化器がん参加施設


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 10 Month 14 Day

Date of IRB

2013 Year 12 Month 20 Day

Anticipated trial start date

2014 Year 01 Month 07 Day

Last follow-up date

2018 Year 04 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 29 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=R000014528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name