UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003507 |
|---|---|
| Receipt number | R000003967 |
| Scientific Title | Phase II trial of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer |
| Date of disclosure of the study information | 2010/04/20 |
| Last modified on | 2018/09/27 11:22:06 |
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Basic information
Public title
Phase II trial of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer
Acronym
N-SOG 03
Scientific Title
Phase II trial of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer
Scientific Title:Acronym
N-SOG 03
Region
| Japan |
Condition
Condition
Locally advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficasy of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Treatment compliance
Key secondary outcomes
Overall survival, disease free survival, local recurrence rate, response 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 chemotherapy with XELOX plus Bevacizumab followed by surgery
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Writen informed consent
2.Histologically proven adenocarcinoma of the rectum
3. Clinical confirmed locally advanced rectal cancer
4. Without distant metastases (M0)
5. Age: 20-80 years
6. Performance status (PS) 0-1
7. Alife expectancy greater than 12 weeks
8. Without prior radiotherapy for the pelvis
9. Adequate organ function
Key exclusion criteria
1. Multiple malignacies to be treated
2. Uncontrollable peptic ulcer disease
3. Serious complications
4. Previous history of severe drug-induced allergy
5. Severe neuropathy
6. With interstitial lung disease or pulmonary fibrosis
7. Pregnant
8. Prior chemotherapy with bevacizumab, oxaliplatin or capecitabin
9. Disqualified by attending docor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Uehara |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
Homepage URL
kuehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Surgical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/23935207
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/21803876
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
| 2010 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | 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
| 2010 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003967
