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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024330
Receipt No. R000027804
Scientific Title A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
Date of disclosure of the study information 2016/10/07
Last modified on 2016/10/07

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Basic information
Public title A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
Acronym A phase II study of UFT/LV and bevacizumab treatment
Scientific Title A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
Scientific Title:Acronym A phase II study of UFT/LV and bevacizumab treatment
Region
Japan

Condition
Condition unresectable metastatic/recurrent colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigated the efficacy and safety of combination therapy of UFT/LV and Bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer.
Basic objectives2 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 Overall survival, Time to treatment failure, Overall response rate, Disease control rate, Adverese

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(75mg/day) are simultaneously given 3times per day for 5days, followed by 2-day rest. Bevacizumab is administerd by every 3 weeks.
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) Patients with histologically verified adenocarcinoma of the colon and rectum
2) Patients with Unresectable metastatic/recurrent colorectal cancer
3) Patients not appropriate for intensive therapy, such as FOLFOX or FOLFIRI
4) Patents without a previous chemotherapy or radiation therapy
5) Patient's age over 20 years-old
6) ECOG Performance status of 0-2
adequate bone marrow, liver, renal, and cardiac function; no prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; ; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.
Key exclusion criteria 1)Patients with a past history of severe drug allergy 2)no other co-existing malignancy or malignancy within the last five years prior to enrollment other than non-melanoma skin cancer or in situ carcinoma of the cervix 3)patients were pregnant or lactating 4)Patients with psychiatric illness 5)Patients with severe co-morbidities (renal failure, liver dysfunction, uncontrolable diabetes mellitus and hypertension, heart failure) 6)Patients with massive ascites or hydrothorax 7)Patients with a symptomatic brain metastasis 8)Patients with abdominal surgery within 28days 9)Patients with perforated disease 10)Patients with thrombosis 11)Patiens with 3+ proteinurea
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Maeda
Organization Osaka City University Graduate School of Medicine
Division name Dept of Surgical Oncology
Zip code
Address Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3838
Email m1378386@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Maeda
Organization Osaka City University Graduate School of Medicine
Division name Dept of Surgical Oncology
Zip code
Address Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3838
Homepage URL
Email m1378386@med.osaka-cu.ac.jp

Sponsor
Institute Dept of Surgical Oncology Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Dept of Surgical Oncology Osaka City University Graduate School of Medicine
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
2016 Year 10 Month 07 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
Date of protocol fixation
2016 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 26 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
2016 Year 10 Month 07 Day
Last modified on
2016 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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