UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000003515
Receipt No. R000004261
Scientific Title Phase II study of bevacizumab combined with oral leucovorin plus UFT for elderly patients with metastatic colorectal cancer.
Date of disclosure of the study information 2010/04/26
Last modified on 2019/03/28 (Ver. 7)

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Basic information
Public title Phase II study of bevacizumab combined with oral leucovorin plus UFT for elderly patients with metastatic colorectal cancer.
Acronym Phase II study of bevacizumab combined with oral leucovorin plus UFT for elderly patients with metastatic colorectal cancer.
Scientific Title Phase II study of bevacizumab combined with oral leucovorin plus UFT for elderly patients with metastatic colorectal cancer.
Scientific Title:Acronym Phase II study of bevacizumab combined with oral leucovorin plus UFT for elderly patients with metastatic colorectal cancer.
Region
Japan

Condition
Condition advanced and recurrent colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of oral leucovorin+UFT+Bevacizumab combination for elderly patients with 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 Progression-free survival
Key secondary outcomes Safety
Overall survival
Response rate

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 Bevacizumab 5mg/kg is administered intravenous injection on day 1,15.
UFT 300mg/m2/day and LV 75mg/body/day is administered orally for 21 days every 28 days.
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
2)Patients with confirmed target lesion
3)Patients with no prior chemotherapy
4)Patients with no prior radiotherapy
5)Patients of age=>75
6)Performance Status0-1(ECOG)
7)Patients with expected life for at 3 months
8)Sufficient organ functions
WBC>=3000/mm3 and <=12000/mm3
Neutrophils>=1500/mm3
Hemoglobin>=9.0g/dl
Platelets>=100000/mm3
AST/ALT<=100IU
Total bilirubin<=1.5mg/dl
Creatinine<=1.5mg/dl
normal EKG
9)Written informed consent
10)Capability of oral intake
Key exclusion criteria 1)Concurrent treatment with prohibited medications, including phenytoin
2)Administration contraindication of UFT, leucovorin and bevacizumab
3)Serious infection
4)HBsAg potitive
5)Active double cancer
6)Uncontrolled hypertention
7)Severe complications
8)Massive pleural or abdominal effusion
9)Patient with the diarrhea
10)Brain metastasis
11)Uric protein 2+
12)Men of the fertility hope
13)Pregnant or lactating female at any time during study
14)Systemic administration of corticosteroids
15)Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction
16)Patients who underwent surgery within 4 weeks
17)Systemic administration of antiplatelet drug
18)Patients with known bleeding disorders or clotting disorder
19)Severe mental illness
20)Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name Tomohiro
Middle name
Last name Nishina
Organization National hospital organizaion shikoku cancer center
Division name Department of internal medicine
Zip code 791-0280
Address 160 kou minamiumemotomachi Matsuyama city Ehime, Japan
TEL 089-999-1111
Email tnishina@shikoku-cc.go.jp

Public contact
1st name of contact person
1st name Tomohiro
Middle name
Last name Nishina
Organization National hospital organizaion shikoku cancer center
Division name Department of internal medicine
Zip code 791-0280
Address 160 kou minamiumemotomachi Matsuyama city Ehime, Japan
TEL 089-999-1111
Homepage URL
Email tnishina@shikoku-cc.go.jp

Sponsor
Institute Tukuba cancer clinical trial group
Shikoku gastrointestinal oncology study group
Institute
Department

Funding Source
Organization Tukuba cancer clinical trial group
Shikoku gastrointestinal oncology study group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB shikoku cancer center
Address Ehime prefecture matsuyamashi minamiumemotomachi kou 160
Tel 089-999-1111
Email tnishina@shikoku-cc.go.jp

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 26 Day

Related information
URL releasing protocol NA
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26778644
Number of participants that the trial has enrolled 55
Results 
Of the 55 patients enrolled. Their median age was 80 years (range, 75-87 years)
The median PFS was 8.2 months (95% confidence interval [CI], 6.2-10 months).
UFT/LV (3 weeks of therapy and 1 week without) combined with biweekly bevacizumab is a tolerable and effective treatment option for elderly patients (aged over 75 years) with metastatic colorectal cancer.
Results date posted
2019 Year 03 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
OVER 75 years, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, first-line chemotherapy, measurable lesions, and preserved organ function.
Participant flow 
A total of 55 patients were enrolled from 15 institutions between August 2008 and March 2012.
Adverse events 
The most common grade 3 and 4 treatment-related adverse events were hypertension (12%), fatigue (8%), anemia (8%), nausea (6%), and diarrhea (6%). Treatment-related death occurred in 2 patients.
Outcome measures 
0. The median PFS was 8.2 months (95% confidence interval [CI], 6.2-10 months).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 07 Day
Date of IRB
2008 Year 09 Month 29 Day
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 15 Day
Date trial data considered complete
2014 Year 03 Month 27 Day
Date analysis concluded
2014 Year 05 Month 25 Day

Other
Other related information NA

Management information
Registered date
2010 Year 04 Month 20 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004261