UMIN-CTR Clinical Trial

Public title

Phase II study of perioperative chemotherapy (preoperative XELOX+Bevacizumab/ postoperative XELOX) in patients with locally advanced rectal cancer

Acronym

pedioperative chemotherapy study of XELOX +bevacizumab for locally advanced rectal cancer.(RUDDER Trial)

Scientific Title

Phase II study of perioperative chemotherapy (preoperative XELOX+Bevacizumab/ postoperative XELOX) in patients with locally advanced rectal cancer

Scientific Title:Acronym

pedioperative chemotherapy study of XELOX +bevacizumab for locally advanced rectal cancer.(RUDDER Trial)

Region

Japan

Condition

Rectal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of preoperative XELOX + bevacizumab and postoperative XELOX 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

Primary outcomes

Treatment completion rate

Key secondary outcomes

safety(perioperative complications, adverse events by chemotherapy), 3-year recrence free survival rate, 3-year local recurrence-free survival rate, 3-year overall survival rate, R0 resection rate, pathological effect, relative dose intensity, overall response rate, down- staging rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After 4cycle of preoperative XELOX+Bevacizumab(BV(-)at 4th cycle),primary resection is to be perfomed.Primary resection have to be done with in 4-8 weeks after last dose of Capecitabine.After resection,4cycles of postoperative XELOX to be administered.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Written informd consent
2.Rectal cancer with inferir edge located below peritoneal reflection,histologically adeno
3..cT2 N1,cT3 N0-1
4.20-80 years old
5.ECOG PS0-1
6.Life expect ancy from the day of eneollment is 3 months or longer
7.No prior radiotherapy
8.Major organ functions less than 14 days prior to entty meet the following criteria
(Neutrophil count>=1500/mm3,Platelet count>=100.000/mm3,Hb>=9.0dl,T-Bil<=2.0mg/dl,AST ALT<=100U/L,Cre Men <1.8mg/dl female<1.35mg/d)

Key exclusion criteria

1. Need to drain malignant coelomic fluid;
2.Multiple primary cancer within 5years
3. Bleeding tendency, coagulation factor or abnormal clotting disorder (INR 1.5)
4. Intestinal paralysis, intestinal obstruction, peptic ulcer uncontrollable
5.Serious complications (diabetes, infections, diarrhea)
6. Symptomatic or asymptomatic but treated heart disease. History of those within one year prior to enrollment
7. History of the serious hypersensitivity for fluorouracil, platinum compound. History of adverse events related to DPD loss
8. Peripheral sensory neuropathy (CTCAE v4.0 Grade 1);
9.Pulmonary fibrosis or interstitial pneumonia
10. Current or previous (within the last 1 year) history of cerebrovascular disease
11.Administered antithrombotic agents for thrombosis within 10 days prior to enrollment
12. Serious hypertension
13. History of gastrointestinal perforation
14.Pregnant women,possibly pregnant women, wishing to become pregnant, and nursing mothers;
15.No intention to practice birth control;
16.Previously treated with oxaliplatin;or capecitabine
17.Any other medical conditions disable to comply with the protocol

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Masahito Kotaka, MD

Organization

Sano Hospital

Division name

Gastrointestinal Cancer Center

Zip code

Address

2-5-1 Shimizugaoka,Tarumi-ku,Kobe, Hyogo,Japan

TEL

078-785-1000

Email

tomomakotaka6410@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Masahito Kotaka, MD

Organization

Sano Hospital

Division name

Gastrointestinal Cancer Center

Zip code

Address

2-5-1 Shimizugaoka,Tarumi-ku,Kobe, Hyogo,Japan

TEL

078-785-1000

Homepage URL

Email

tomomakotaka6410@yahoo.co.jp

Institute

Sano Hospital Masahito Kotaka, MD

Institute

Department

Personal name

Organization

None

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

2014

Year

01

Month

28

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

Enrolling by invitation

Date of protocol fixation

2013

Year

11

Month

15

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

01

Month

28

Day

Last modified on

2015

Year

02

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015018