UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039783
Receipt number R000045372
Scientific Title A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer
Date of disclosure of the study information 2020/03/12
Last modified on 2020/03/12 09:42:24

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Basic information

Public title

A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer

Acronym

Phase II study of XELOXIRI+Bevacizumab

Scientific Title

A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer

Scientific Title:Acronym

Phase II study of XELOXIRI+Bevacizumab

Region

Japan


Condition

Condition

metastatic colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of CPT-11 + L-OHP + capecitabine + Bevacizumab therapy for metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall survival, response rate, safety, R0 resection rate, efficacy by the RAS mutation status, QOL


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

irinotecan, oxaliplatin, capecitabine, 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed advanced metastatic/recurrent colorectal cancer.
2. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment.
3. Age :20-75 years
4. Wild or hetero type of UGT1A1*28 or *6 genotype
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
6. Vital organ functions (listed below) are preserved within a week prior to entry.
7. Survival more than 3 months.
8. Written informed consent.

Key exclusion criteria

1. Need to drain malignant fluid.
2. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium.
3. Pregnant or lactating women or women of childbearing potential.
4. Uncontrolled infection.
5. Evidence of interstinal lung disease, or pulmonary fibrosis.
6. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
7. Uncontrollable ulcer indigestive tract.
8. Radiological evidence of CNS metastases or brain cancer.
9. Complication of cerebrovascular disease or symptoms within 1 year.
10. Any surgical treatments within 4 weeks.
11. Administering antithrombotic drug within 10 days. Need to administrate or having anti-platelets therapy
12. Multiple primary cancers within 5 years.
13. Other conditions not suitable for this study.

Target sample size

47


Research contact person

Name of lead principal investigator

1st name Ohnuma
Middle name
Last name Hiroyuki

Organization

Sapporo Medical University School of Medicine

Division name

Department of Medical Oncology

Zip code

060-0061

Address

S-1, W-16, Chuo-ku, Sapporo

TEL

011-611-2111

Email

ohnuma@sapmed.ac.jp


Public contact

Name of contact person

1st name Ohnuma
Middle name
Last name Hiroyuki

Organization

Sapporo Medical University School of Medicine

Division name

Department of Medical Oncology

Zip code

060-0061

Address

S-1, W-16, Chuo-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

ohnuma@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical trial center, Sapporo Medical University

Address

S-1, W-16, Chuo-ku, Sapporo

Tel

011-611-2111

Email

kenkyusien@sapmed.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2014 Year 11 Month 20 Day

Date of IRB

2014 Year 12 Month 17 Day

Anticipated trial start date

2014 Year 12 Month 22 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 12 Day

Last modified on

2020 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name