UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II trial of SOX plus bevacizumab or cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer (OITA-trial II)
Acronym	OITA-trial II
Scientific Title	A Phase II trial of SOX plus bevacizumab or cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer (OITA-trial II)
Scientific Title:Acronym	OITA-trial II
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 efficacy and safety of SOX+bevacizumab or SOX+cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes	DFS, OS, Response rate, pathological Response, Safety, Rate of complete treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 80 mg/m2 p.o. (day1-14) L-OHP 130 mg/m2(day 1) [ KRAS-MT ] bevacizumab 7.5mg/kg(day 1) to be repeated every 3 week until 3 course or to meet discontinuation criteria
Interventions/Control_2	S-1 80 mg/m2 p.o. (day1-14) L-OHP 130 mg/m2(day 1) [ KRAS-WT ] cetuximab 250mg/m2 (day 1, 8, 15) to be repeated every 3 week until 3 course or to meet discontinuation criteria
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) Histologically confirmed rectal cancer (Ra, Rb, P) 2) Histologically confirmed adenocarcinoma 3) Clinical stage T3-4, N0-2(UICC 7th edition) 4) Age of 20 to 80 years old 5) PS(ECOG) 0-1 6) Confirmed KRAS status 7) Previously untreated rectal cancer (including chemotherapy, radiotherapy, hormonal therapy, or surgery) 8) be able to take oral drugs 9) Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,< 12000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST,ALT <= 100U/L Cre <1.5mg/dl Ccr >= 60mL/min 10) Appropriate for the study at the physician's assessment 11) Written informed consent
Key exclusion criteria	1) History of serious drug hypersensitivity or a history of drug allergy 2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less) 3) Patients with contraindication to each drugs 4) Serious complication ( ex. intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, serious diabetes, serious hypertension cardiac failure, renal failure, or liver failure) 5) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema ) 6) Pleural effusion, peritoneal fluid that needs treatment 7) Positive for HBs antigen 8) Patients who have bleeding from GI tract, intestinal paralysis, intestinal obstruction, peptic ulcer 9) Patients who need flucytosine, phenytoin or warfarin potassium. 10) History of thromboembolism, cerebral infarction or pulmonary infarction 11) Hemorrhagic diathesis, coagulation disorder 12) Requiring anti-thrombogenic therapy to prevent thrombosis 13) History of hemoptysis 14) Requiring consecutive systemic administration of steroid drug 15) Pregnant or lactating woman 16) Man who hope for Partner's pregnant 17) High-grade stricture 18) Not appropriate for the study at the physician's assessment
Target sample size	70

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masafumi INOMATA
Organization	Oita University faculty of medicine
Division name	Department of Gastroenterological and Pediatric Surgery
Zip code
Address	1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
TEL	097-586-5843
Email	geka1@oita-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Masafumi INOMATA
Organization	Oita University faculty of medicine
Division name	Department of Gastroenterological and Pediatric Surgery
Zip code
Address	1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
TEL	097-586-5843
Homepage URL
Email	geka1@oita-u.ac.jp

Sponsor
Institute	Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine
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)

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	大分大学医学部消化器・小児外科学講座、大分大学医学部腫瘍内科、大分医療センター 外科、大分県立病院 外科、大分赤十字病院 外科、健康保険南海病院 外科、中津市民病院 外科、別府医療センター 外科、有田胃腸病院 外科、大分岡病院 外科、大分東部病院 外科、膳所病院 外科、大分県厚生連鶴見病院、九州大学病院別府病院 外科、中津胃腸病院 外科、臼杵市医師会立コスモス病院 外科、津久見中央病院 外科、豊後大野市民病院 外科

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 15 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	2013 Year 03 Month 06 Day
Date of IRB	2013 Year 03 Month 06 Day
Anticipated trial start date	2013 Year 03 Month 06 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 15 Day
Last modified on	2019 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015024