UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005289 |
|---|---|
| Receipt number | R000006290 |
| Scientific Title | Phase 1 study of neoadjuvant chemotherapy with capecitabine/bevacizumab for locally advanced lower rectal cancer. |
| Date of disclosure of the study information | 2011/03/22 |
| Last modified on | 2015/03/23 17:33:09 |
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Basic information
Public title
Phase 1 study of neoadjuvant chemotherapy with capecitabine/bevacizumab for locally advanced lower rectal cancer.
Acronym
Neoadjuvant CRT with capecitabine/bevacizumab for locally advanced lower rectal cancer.
Scientific Title
Phase 1 study of neoadjuvant chemotherapy with capecitabine/bevacizumab for locally advanced lower rectal cancer.
Scientific Title:Acronym
Neoadjuvant CRT with capecitabine/bevacizumab for locally advanced lower rectal cancer.
Region
| Japan |
Condition
Condition
lower rectal cancer
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the MTD and RD of capecitabine plus bevacizumab and preoperative ratiotherapy for locally advanced lower rectal cacer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
MTD, RD
Key secondary outcomes
pCR rate, response rate, R0 resection 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
cepecitabine dose
level o-2
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
1)histologically confirmed rectal adenocarcinoma
2)ECOG PS 0-1
3)T3 or T4 disease or tumors with perirectal nodal involvement
Key exclusion criteria
1)distant organ metastasis
2)previous chemotherapy for colorectal cancer
3)previous radiotherapy for the pelvis
4)history of another malignancy witjin the last 5years
Target sample size
6
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
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 | Kita |
Organization
Osaka City University Hospital
Division name
Department of ethics
Zip code
Address
1-4-3Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-2121
Homepage URL
ethics@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Mediceine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Mediceine
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
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
大阪市立大学大学院医学研究科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 22 | Day |
Last modified on
| 2015 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006290
