UMIN-CTR Clinical Trial

Public title

Pilot study of preoperative chemotherapy of XELOX+ Bevacizumab in patients with locally-advanced lower rectal cancer

Acronym

Pilot study of the preoperative chemotherapy of XELOX+ Bevacizumab in Patients with locally-advanced lower rectal cancer

Scientific Title

Pilot study of preoperative chemotherapy of XELOX+ Bevacizumab in patients with locally-advanced lower rectal cancer

Scientific Title:Acronym

Pilot study of the preoperative chemotherapy of XELOX+ Bevacizumab in Patients with locally-advanced lower rectal cancer

Region

Japan

Condition

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the feasibility of neoadjuvant therapy (XELOX and bevacizumab) in patients with locally-advanced lower rectal cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Safety(Adverse event, Complication)

Key secondary outcomes

Resectability
Down staging rate
Pathological complete response rate Pathological effect

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

Neo-Adjuvant chemotherapy
XELOX+ bevacizumab 3cycle followed by XELOX 1cycle
Resection
3-8weeks after last chemotherapy dose

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) Written informed consent.
(2) Age: 20-74 years old.
(3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
(4) Histological confirmation of rectal cancer.
(5) Clinical stage T4 and/or lymph node positive.
(6) Low rectal cancer.
(7) No prior radio or chemo therapy
(8) Vital organ functions listed below are preserved within 2 weeks prior to entry.
1. WBC 4,000 /mm3 and over
2. Nertrophil 2000 /mm3 and over
3. Platelet 100,000 /mm3 and over
4. Hemoglobin 9.0 g/dl and over
5. Total bilirubin 1.5 ml/dl and less
6. AST and ALT 100 IU/l and less
7. Creatinine 1.5 mg/dl and less

Key exclusion criteria

(1) With malignant coelomic fluid.
(2) With distant metastases
(3) Multiple primary cancer within 5 years
(4) With arterial thromboembolism, e.g. cerebrovascular disease
(5) Any surgical treatments including skin-open biopsy, surgery of trauma and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
(6) Administering antithrombotic drug within 10 days.
(7) Need to administrate or having anti-platelets therapy (including aspirin and NSAIDS)
(8) Bleeding tendency or coagulation disorder (INR 1.5 and over)
(9) Symptom of colorectal obstruction
(10) Uncontrolled complication of peptic ulcer
(11) Current or previous (within the last 1 year) history of GI perforation
(12) Serious renal complications or having 2+ uric protein
(13) Uncontrolled hypertension
(14) Symptomatic or asymptomatic but treated heart disease
(15) History of the serious hypersensitivity for Fluorouracil, platinum compound and levofolinate calcium
(16) History of adverse events related to DPD loss
(17) Uncontrolled Diarrhea
(18) Peripheral neuropathy (Grade1<=)
(19) Uncontrolled infection
(20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(21) No intention to practice birth control
(22) Previously treated with bevacizumab or oxaliplatin
(23) Other conditions not suitable for this study

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Juniti hasegawa

Organization

Osaka rosai hospital

Division name

Dpt surgery

Zip code

Address

1179-3O Nagasone Kita Ward Sakai City Osaka

TEL

Email

Name of contact person

1st name
Middle name
Last name	Masataka Ikeda Tsunekazu Mizushima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Surgery

Zip code

Address

2-2 Yamadaoka Suita City Osaka

TEL

06-6879-3251

Homepage URL

Email

tmizushima@gesurg.med.osaka-u.ac.jp

Institute

Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

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

2010

Year

02

Month

21

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24595805

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

Main results already published

Date of protocol fixation

2009

Year

12

Month

10

Day

Date of IRB

Anticipated trial start date

2010

Year

01

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

2010

Year

02

Month

21

Day

Last modified on

2021

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003532