UMIN-CTR Clinical Trial

Public title

Phase II trial of irinotecan base regimen of bevacizumab for metastatic colorectal cancer progressed on oxaliplatin base regimen of bevacizumab

Acronym

Phase II trial of irinotecan base regimen of bevacizumab for metastatic colorectal cancer progressed on oxaliplatin base regimen of bevacizumab

Scientific Title

Phase II trial of irinotecan base regimen of bevacizumab for metastatic colorectal cancer progressed on oxaliplatin base regimen of bevacizumab

Scientific Title:Acronym

Phase II trial of irinotecan base regimen of bevacizumab for metastatic colorectal cancer progressed on oxaliplatin base regimen of bevacizumab

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of safety and efficacy by irrinotecan based chemotherapy + bevacizumab beyond progression therapy for advanced colorectal cancer patient who treated with bevacizumab + oxaliplatin based chemotherapy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Progression free survival

Key secondary outcomes

Overall response rate, Treatment to failure, Overall survival, Safety, Analysis by age, regimen and UGT1A1

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

Bevacizumab and irrinotecan based chemotherapy (q2w FOLFIRI, q3w XELIRI, q3w/q4w IRIS)

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 bevacizumab as 1st line Oxaliplatin containing regimen
(with measurable lesions in RECIST criteria)
(2) Oxaliplatin and bevacizumab were administrated for more than 4 times in 1stline
(3) Colorectal cancer, cytologically and/or histrogically
(4) Written informed consents
(5) Age: 20 years old and above
(6) Performance Status(ECOG):0~1
(7) Life expectancy estimated >= 3 months
(8) Sufficient organ functions

Key exclusion criteria

(1) Previously irinotecan treatment
(2) Administering transfusion/ hematopoietic factor or antithrombotic drug within 14 days
(3) Serious renal dysfunction
(4) Serious drug hypersensitivity or a history of drug allergy
(5) Active concomitant malignancy
(6) Active infections
(7) Symptomatic or asymptomatic but treated heart disease
(8) History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema
(9) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer
(10) Pleural effusion, peritoneal fluid and pericardial fluid
(11) Symptomatic brain metastasis
(12) History of mental disturbances or cerebrovascular accident
(13) High blood pressure and diabetic that cannot be controlled
(14) Uncontrolled diarrhea
(15) Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study
(16) Traumatic fracture of unrecovery
(17) Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS)
(18) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
(19) Need to treatment with atazanavir sulfate
(20) Paralyzed bowel
(21) Other conditions not suitable for this study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Sugimoto

Organization

Shimane Prefectural Central Hospital

Division name

Department of Surgery

Zip code

Address

4-1-1 Himehara, Izumo city, Shimane prefecture

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Shimane Prefectural Central Hospital

Division name

Department of Surgery

Zip code

Address

TEL

Homepage URL

Email

shin1028@spch.izumo.shimane.jp

Institute

SGCSG: Shimane Gastroenterological Cancer Study Group

Institute

Department

Personal name

Organization

SGCSG: Shimane Gastroenterological Cancer Study Group

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

2013

Year

01

Month

06

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

Open public recruiting

Date of protocol fixation

2012

Year

10

Month

19

Day

Date of IRB

Anticipated trial start date

2012

Year

12

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

2013

Year

01

Month

06

Day

Last modified on

2013

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011371