UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012856
Receipt number R000015024
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)
Date of disclosure of the study information 2014/01/15
Last modified on 2019/03/16 13:16:29

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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

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

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 or person

Institute

Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015024


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name