UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011365 |
|---|---|
| Receipt number | 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 09:31:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
m1378386@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012355
