UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003447
Receipt number R000004170
Scientific Title Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.
Date of disclosure of the study information 2010/04/20
Last modified on 2021/05/25 15:32:42

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Basic information

Public title

Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.

Acronym

Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.

Scientific Title

Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.

Scientific Title:Acronym

Phase II study of chemotherapy with UFT/LV/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer.

Region

Japan


Condition

Condition

advanced and recurrent colorectal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical effectiveness and toxicity of UFT/LV/Bevacizumab combination chemotherapy for elderly advanced and recurrent colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Overall response rate

Key secondary outcomes

Disease-free survival
Overall survival


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

UFT 300mg/m2/day and LV 50mg/body/day is administered orally for 21 days every 28 days.
Bevacizumab 5mg/kg is administered intravenous injection on day 1,15.

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with pathologically proven colorectal cancer(adenocarcinoma)
2)Patients with unrecectable advanced and recurrent colorectal cancer
3)Patients with confirmed target lesion
4)Patients with no prior chemotherapy
5)Patients with no prior radiotherapy
6)Patients of age =>75
7)Performance Status:0-2(ECOG)
8)Patients with not enforceable intensive chemotherapy
9)Patients with expected life for at 90 days
10)Sufficient organ functions
i. neutrophils>=1,500/mm3
ii. platelets>=100,000/mm3
iii. hemoglobin>=9.0g/dL
iv. total bilirubin<=1.5mg/dL
v. AST/ALT<=100IU(or <=150IU if liver metastases were present)
vi.serum creatinine<=1.5mg/dL
11)Capability of oral intake
12)Written informed consent

Key exclusion criteria

1)Medical history of severe anaphylazis or allergia to any drug
2)Active double cancer
3)Serious infection
4)Uncontrolled hypertention
5)Severe complication
6)Massive pleural or abdominal effusion
8)Brain metastasis
9)Severe mental illness
10)Systemic administration of corticosteroids
11)Uric protein 2+
12)Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction
13)Patients who underwent surgery within 4 weeks
14)Systemic administration of antiplatelet drug
15)Patients with known bleeding disorders or clotting disorder
16)Patients who are judged inappropriate for the entry into the study by the investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Tamagawa

Organization

Otemae Hospital

Division name

Department of Surgery

Zip code


Address

1-5-34 Otemae Chuou Osaka-city Osaka, Japan

TEL

06-6941-0484

Email

hiroh2jr@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masataka Ikeda Tsunekazu Mizushima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Surgery

Zip code


Address

2-15 Yamadaoka Suita-city Osaka,Japan

TEL

06-6879-3251

Homepage URL


Email

tmizushima@gesurg.med.osaka-u.ac.jp


Sponsor or person

Institute

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.karger.com/Article/Abstract/381718

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

Main results already published

Date of protocol fixation

2010 Year 03 Month 24 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 04 Month 04 Day

Last modified on

2021 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004170


Research Plan
Registered date File name
2016/07/06 高齢者進行・再発大腸癌に対するUFTLV(分2)+Bevacizumab療法の第Ⅱ相臨床試験.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name