UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003515 |
|---|---|
| Receipt number | 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 16:36:13 |
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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
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
tnishina@shikoku-cc.go.jp
Public contact
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
tnishina@shikoku-cc.go.jp
Sponsor or person
Institute
Tukuba cancer clinical trial group
Shikoku gastrointestinal oncology study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004261
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