UMIN-CTR Clinical Trial

Public title

A phaseI trial of S-1 Oxaliplatin and Bevacizumab in combination with Radiotherapy for Neozdjuvant Therapy of Locally advanced lower rectal cancer

Acronym

Phase I of Neoadjuvant CRT with SOX/Bev+RT

Scientific Title

A phaseI trial of S-1 Oxaliplatin and Bevacizumab in combination with Radiotherapy for Neozdjuvant Therapy of Locally advanced lower rectal cancer

Scientific Title:Acronym

Phase I of Neoadjuvant CRT with SOX/Bev+RT

Region

Japan

Condition

Resectable lower rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the RD of S-1/Oxaliplatin/Bevacizumab with RT for locally advancced rectal cancer at neoadjubant therapy

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

MTD,RD

Key secondary outcomes

pCR rate,response rate,safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 day1-5,8-12,15-19,22-26,65-80mg/m2 orally
Oxaliplatin day1,8,15,22,dose of 40-60mg/m2 iv
bevacizumab day1,15,dose 5mg/kg iv
Radiotherapy 2Gy/day day1-5,8-12,15-19,22-26,total 40Gy
surgery after 6-8week rest

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Histologically confirmed Rectal Cancer
2)T1N1-T4(by CT or EUS)
3)Tumor reached lower rectal
4)with target lesion by RECIST
5)No evidence of peritoneal metastasis
6)No evidence of distant metastasis
7)Age of 20-75years old
8)PS(ECOG):0-2
9)Adequate organ function
10)Without prior anti-cancer therapy
11)written IC
12)Adequate oral intake

Key exclusion criteria

1)With interstitial pneumotitis or pulmonary fibrosis
2)With ascites for need to cure
3)Prior or synchronous invasive malignancy(expect carcinoma in situ or superfivcial carcinoma which is able to eradicate by local therapy)unless disease free for a minimun of 5 years
4)With infection,bowel paralysis or bowel obstruction
5)With severe watery diarrhea
6)With uncontrolled diabetic mellitus
7)With uncontrolled hypertension
8)With Heart disease,hepatic failure,renal failure which is difficult to enroll
9)With brain metastasis
10)Pregnant or lactating and woman with childbearing potential who lacked effective contraception
11)Previous history of sever drug-induced allergy
12)Previous history of drug-induced allergy with Testing drugs
13)Evidence of psychiatric disability interfering with enrollment to clinical trial
14)Need systemic administration of corticosteroids
15)Evidence of thorombisis,cerebral infarction,myocardial infarction,pulmonary infarction
16)With peritonitis
17)With congenital bleeding tendency or coagulopathy
18)Need anti-coagulability drugs
19)Evidence of spit blood
20)Evidence of sever sensory disturbance
21)Previous history of sever drug-induced allergy with plutina-drugs
22)Patients judged inappropriate for this study by the physicians

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuo Shimada

Organization

Tokushima University Hospital

Division name

Dept. of Digestive and Pediatric Surgery

Zip code

Address

3-18-15 Kuramoto-cho,Tokushoma,Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Tokushima University Hospital

Division name

Dept. of Digestive and Pediatric Surgery

Zip code

Address

-18-15 Kuramoto-cho,Tokushoma,Japan

TEL

088-633-7139

Homepage URL

Email

Institute

Tokushima University Hospital
Dept. of Digestive and Pediatric Surgery

Institute

Department

Personal name

Organization

Tokushima University Hospital
Dept. of Digestive and Pediatric Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2012

Year

01

Month

04

Day

Date of IRB

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

12

Month

22

Day

Last modified on

2011

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008200