UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer
Title of the study (Brief title)	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	Masato Nagino
Organization	Nagoya University Graduate School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
Email

Public contact
Name of contact person	Keisuke Uehara
Organization	Nagoya University Graduate School of Medicine
Division name	Division of Surgical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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