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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011365
Receipt No. R000012355
Scientific Title Phase II study of neoadjuvant bevacizumab with weekday-on/weekday-off capecitabine and radiation for locally advanced rectal cancer
Date of disclosure of the study information 2013/08/03
Last modified on 2016/08/05

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Basic information
Public title Phase II study of neoadjuvant bevacizumab with weekday-on/weekday-off capecitabine and radiation for locally advanced rectal cancer
Acronym Neoadjuvant bevacizumab with capecitabine and radiatiotherapy
Scientific Title Phase II study of neoadjuvant bevacizumab with weekday-on/weekday-off capecitabine and radiation for locally advanced rectal cancer
Scientific Title:Acronym Neoadjuvant bevacizumab with capecitabine and radiatiotherapy
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery Radiology
Operative medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the efficacy of the neoadjuvant bevacizumab with capecitabine adn radiation for locally advanced rectal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes pCR rate
Key secondary outcomes response rate,rate of R0 resection,
3-years survival 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 neoadjuvant chemoradiotherapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Eligible patients had to have a histologically verified adenocarcinoma of the rectum with the inferior margin within 5cm from the anal verge, as assessed by rectosigmoidoscopy.
The tumor had to have evidence of T3/T4 disease or any T disease with positive locoregional lymphnodes detected by computed tomography (CT) and magnetic resonance imaging (MRI) of the pelvis. The disease was considered to be resectable at the time of entry in all cases, with no evidence of distant metastases.
Key exclusion criteria prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; 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; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.
Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Maeda
Organization Osaka City University
Division name Department of Surgical Oncology
Zip code
Address 1-4-3Asahimachi, Abeno-ku, Osaka, Japan
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 Hospital
Division name Department of Surgical Oncology
Zip code
Address 1-4-3Asahimachi, Abeno-ku, Osaka, Japan
TEL 06-6645-3838
Homepage URL
Email m1378386@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Osaka City University
Organization
Division
Category of Funding Organization Outside Japan
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 大阪市立大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 03 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 03 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012355

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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