UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer
Title of the study (Brief title)	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	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	Self funding
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	2010 Year 04 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 01 Month 28 Day
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

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/23935207
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/21803876
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003967