UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005199
Receipt number R000006173
Scientific Title Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer
Date of disclosure of the study information 2011/03/05
Last modified on 2011/12/19 23:03:27

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Basic information

Public title

Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Acronym

Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Scientific Title

Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Scientific Title:Acronym

Phase II study of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Region

Japan


Condition

Condition

Metastatic colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Bevacizumab with SOX (S-1 plus L-OHP) as second-line therapy in metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Progression Free Survival(PFS)
Overall Survival(OS)
Safety


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

Bevacizumab with SOX (S-1 plus L-OHP) repeat every 21 days until discontinuance criteria.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients with histologically proven colorectal cancer
(2) Metastatic colorectal cancer
(3) Patients with comfirmed target lesion
(4) Patients with metastatic colorectal cancer who had previously received first-line therapy with an irinotecan-based regimen.
(5) Life expectancy of more than 3 months
(6) Age over 20
(7) ECOG Performance Status 0-1
(8) Patients have enough organ function for study treatment.
(9) Enable to internal use
(10) Written informed consent

Key exclusion criteria

(1) History of severe allergy
(2) Active double cancer
(3) Severe infectious disease
(4) Peripheral neuropathy
(5) Uncontrolled hypertention
(6) Sever comorbidity(interstitial lung disease or pulmonary fibrosis, heart failure, renal failure, liver failure, etc)
(7) Massive pleural or abdominal effusion
(8) Patient with the diarrhea
(9) Symptomatic brain metastases
(10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
(11) Severe mental disorder
(12) Systemic administration of corticosteroids
(13) Uric protein 2+
(14) Prior radiotherapy for primary and metastases tumors
(15) Thrombosis, cerebral infraction, cardiac infraction or pulmonary infraction within 6 months
(16) Patients who underwent surgery within 4 weeks
(17) Systemic administration of antiplatelet drug
(18) Patients with known bleeding disorders or clotting disorder
(19) Previous history of adjuvant chemotherapy with L-OHP
(20)Any other cases who are regarded as inadequate for study enrollmet by investigators

Target sample size

33


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Sakai

Organization

Tsuchiura kyodo general hospital

Division name

Department of Gastroenterology

Zip code


Address

11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshiki Masuishi

Organization

Tsuchiura kyodo general hospital

Division name

Department of Gastroenterology

Zip code


Address

11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Tsuchiura kyodo general hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

2011 Year 03 Month 05 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

Terminated

Date of protocol fixation

2011 Year 01 Month 24 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 03 Month 05 Day

Last modified on

2011 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006173


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name