UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002920 |
|---|---|
| Receipt number | R000003558 |
| Scientific Title | Phase II trial of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer |
| Date of disclosure of the study information | 2009/12/21 |
| Last modified on | 2018/09/27 11:15:32 |
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Basic information
Public title
Phase II trial of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer
Acronym
N-SOG 02
Scientific Title
Phase II trial of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer
Scientific Title:Acronym
N-SOG 02
Region
| Japan |
Condition
Condition
Resectable local recurrent rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
overall survival, 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
Neoadjuvant chemotherapy with mFOLFOX6 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Clinical confirmed local recurrent rectal cancer
i. resectable
ii. need for combined resection of adjacent organs or structures
iii. without extra-pelvic metastases
2. Without prior chemotherapy with oxaliplatin or bevacizumab
3. Performance status (PS) 0-1
4. Age: 20-74 years
5. Alife expectancy greater than 12 weeks
6. Adequate organ function
7. Written informed consent
Key exclusion criteria
1. Unresectable local recurrent rectal
cancer
2. Active infections
3. With brain metastases
4. Severe neuropathy
5. Pregnant
6. Prebious history of severe drug-induced allergy
7. Serious complications
8. With interstitial lung disease or pulmonary fibrosis
9. Multiple malignancies to be treated
10. Uncontrollable peptic ulcer disease
11. Disqualified by attending doctor
Target sample size
25
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
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | 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
| 2009 | Year | 12 | 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=R000003558
