UMIN-CTR Clinical Trial

Public title

Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer as first-line chemotherapy

Acronym

Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer

Scientific Title

Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer as first-line chemotherapy

Scientific Title:Acronym

Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer as first-line chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Progression free survival, Overall Survival,
1-year survival rate, Disease control rate, Dose Intensity, Safety

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

Capecitabine plus oxaliplatin(L-OHP: 100mg/m2) with bevacizumab

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proved colon cancer(adenocarcinoma)
2) Advanced or recurrent colorectal cancer that is not amenable to curative resection,and first line chemotherapy
3) >=20years-old
4) ECOG performance status 1-2
5) With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
6) Life expectancy greater than or equal to 3 months
7) Patient of possible oral ingestion
8) Adequate organ function
9) Patient who doesn't have cerebral metastasis
10)Written informed consent
11) Other conditions suitable for this study

Key exclusion criteria

1) History of the serious hypersensitivity for Fluorouracil , Levofolinate calcium,platinum or bevacizumab
2) History of adverse events related to DPD loss
3) Active multiple Primary cancer within 5 years
4) Uncontrolled diarrhea
5) Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
6) Complication of cerebrovascular disease or symptoms within 1 years
7) Administering antithrombotic drug within 10 days before enrollment
8) Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS)
9) Evidence of bleeding diathesis or
coagulopathy
10) Symptom of colorectal obstruction
11) uncontrolled complication of peptic ulcer
12) Current or previous (within the last 1 year) history of GI perforation
13) Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry
14) Uncontrolled Hypertension
15) Uncontrolled Infection
16) Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
17) Man who doesn't practice birth control
18) Other conditions not suitable for this study

Target sample size

52

Name of lead principal investigator

1st name	Taro
Middle name
Last name	Satoh

Organization

Osaka University Hospital

Division name

Department of Frontier Science for Gastrointestinal Cancers and Chemotherapy

Zip code

565-0871

Address

2-2 Yamadaoka Suita City Osaka

TEL

06-6879-3251

Email

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

Name of contact person

1st name	Tsunekazu
Middle name
Last name	Mizushima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Surgery

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka 565-0871,Japan

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

Ethical Review Board of Osaka University Hospital

Address

2-15 Yamadaoka Suita City Osaka

Tel

06-6879-5685

Email

rinri@hp-crc.med.osaka-u.ac.jp

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

04

Month

09

Day

URL releasing protocol

https://ar.iiarjournals.org/content/42/4/1859.long

Publication of results

Published

URL related to results and publications

https://ar.iiarjournals.org/content/42/4/1859.long

Number of participants that the trial has enrolled

56

Results

Between 2012 and 2016, 56 patients were enrolled. The median age was 71 years (range=44-85 years), and the majority (90.6%) had a PS of 1. A complete response was observed in three patients (5.7%), partial response in 24 (45.3%), stable disease in 22 (43.4%), and progressive disease in one (1.9%). The median progression-free survival and overall survival were 11.4 and 26.5 months, respectively. The most common grade 3-4 adverse events were leucopenia (15.1%), neutropenia (9.4%), neuropathy (9.4%).

Results date posted

2022

Year

10

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The study included patients with metastatic colorectal cancer (mCRC) with performance status (PS) of 1 or 2 who had not undergone chemotherapy. Patients received oxaliplatin (100 mg/m2) plus bevacizumab (7.5 mg/kg) on day 1 and capecitabine (2,000 mg/m2/day) on days 1-14 of a 21-day cycle.

Participant flow

This was a phase II, multicenter, open-label, single-arm, prospective, study conducted at 14 Japanese institutions.

Adverse events

The most common grade 3-4 adverse events were leucopenia (15.1%), neutropenia (9.4%), neuropathy (9.4%).

Outcome measures

The primary endpoint was the objective response rate. The secondary endpoints were progression-free and overall survival, 1-year survival rate, disease control rate, dose intensity, and adverse events.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

04

Month

02

Day

Date of IRB

2012

Year

04

Month

01

Day

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

2017

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

None

Registered date

2012

Year

04

Month

04

Day

Last modified on

2022

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009031