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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002920
Receipt No. 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

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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
Email

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
Email kuehara@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Surgical Oncology Group
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003558

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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