UMIN-CTR Clinical Trial

Public title

To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy -PhaseI/II Study

Acronym

To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy- PhaseI/II Study

Scientific Title

To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy -PhaseI/II Study

Scientific Title:Acronym

To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy- PhaseI/II Study

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Phase I part: To decide Recommended dose
Phase II part: Progression Free Survival

Key secondary outcomes

Response rate,Disease control rate,safety,Overall survival, Overall survival from first line Second progression free survival (Progression Free Survival from first line)Case who has bevacizumab treatment in Registered patient,

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

XELIRI+ 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)Disease progression(PD)
or difficult to continue for other reason after chemotherapy with Oxaliplatin containing regimen
2)Histological confirmation of colorectal cancer.
3) Advanced or recurrent colorectal cancer that is not amenable to curative resection.
4) Age: 20 years old or more
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
7) Life expectancy greater than or equal to 3 months
8) Vital organ functions are preserved within 14 days prior to entry
Patients with UGT1A1 genotype
It doesn't have the homo and it has heterozygote of *6,*28.
9) Patient of possible oral ingestion
10) Patient who doesn't have cerebral metastasis
11)Written informed consent
12) Other conditions suitable for this study

Key exclusion criteria

1) Treatment history of irinotecan
2)History of the serious hypersensitivity for Fluorouracil or bevacizumab
3) Treatment with tegafur gimestat otastat potassium Within 7 days
4) Active multiple Primary cancer within 5 years
5)History of adverse events related to DPD loss
6) Uncontrolled diarrhea
7)Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
8)Complication of cerebrovascular disease or symptoms within 1 years
9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS)
10)Evidence of bleeding diathesis or
coagulopathy
11)History of thrombosis and embolism,interstitial pneumonitis,pulmonary fibrosis or high-grade pulmonary emphysema
12)Blood transfusion,administration products support or Administering antithrombotic drug within 14 days before enrollment
13)Pleural effusion,ascites,or pericardial effusion requiring drainage
14)Symptom of colorectal obstruction
15)Freash gastrointestinal bleeding,intestinal paralysis or obstruction,uncontrolled complication of peptic ulcer
16) Current or previous (within the last 1 year) history of GI perforation
17)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry
(18)Uncontrolled Hypertension and diabetes mellitus
(19)Uncontrolled Infection
20)Symptomatic brain metastasis
21)History of central nervous /cerebrovascular accident,uncontrolled mental disturbances
22)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
23)Receiving Atazanavir Sulfate
24)Paralytic bowel obstruction
25) Other conditions not suitable for this study

Target sample size

51

Name of lead principal investigator

1st name
Middle name
Last name	Mutsumi Hukunaga

Organization

Sakai Municipal Hospital

Division name

Surgery

Zip code

Address

1-1-1 minamiyasuityo sakai-ku sakai city Osaka

TEL

072-221-1700

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

2-15 yamadaoka Suita City Osaka

TEL

06-6879-3251

Homepage URL

Email

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

Institute

Multicenter Study Group of Osaka (MCSGO), 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

大阪大学消化器外科関連施設

Date of disclosure of the study information

2010

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28510802

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

2010

Year

05

Month

21

Day

Date of IRB

Anticipated trial start date

2010

Year

07

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

07

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=R000004730