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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005289
Receipt No. 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

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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
Email 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
Email ethics@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Mediceine
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006290

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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