UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022437
Receipt number R000025859
Scientific Title TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial
Date of disclosure of the study information 2016/08/01
Last modified on 2016/05/24 20:25:39

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Basic information

Public title

TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial

Acronym

TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC2 study)

Scientific Title

TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial

Scientific Title:Acronym

TAS-102 and Bevacizumab as second line chemotherapy for colorectal cancer. Phase 2 trial (TAS-CC2 study)

Region

Japan


Condition

Condition

metastatic colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The efficacy and safety of TAS-102 plus Bevacizumab combination as second line therapy for colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

progression free survival

Key secondary outcomes

Time to Treatment Failure, response rate , overall survival


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

TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period
Bevacizumab: 5mg/kg given intravenously in a 2-week cycle

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven colorectal cancer
2) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
3) treatment history of one regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study
4) 20<= and 80>= years old
5) ECOG performance status of 0 or 1
6) With measurable lesions according
7) ability to tolerate oral drug administration
8) standard second therapy not eligibility
9) a life expectancy of at least 3 months
10) Patient who has adequate main organ functions in tests within 14 days before enrollment leukocyte >=3,500/mm3 neutrophil >=1,500/mm3 platelet >=75,000/mm3 haemoglobin concentorarion >=8.0 g/dL serum total bilirubin level <=1.5 mg/dL serum creatinine <=1.5 mg/dL serum AST and ALT levels <2.5x Upper limit of normal (ULN). serum creatinine <=1.5 mg/dL Peripheral neuropathy<=grade2 Diarrhea and NonHaematotoxicity =<grade1
11) gave written informed consent

Key exclusion criteria

1) contraindications for TAS-102 and Bevacizumab
2) previously received chemotherapy with TAS-102
3) severe drug allergy
4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy.
5) patient who has important clinical complications (symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.)
6) other active malignancies
7) have pleural effusion and ascitic fluid with the treatment
8) Comorbidity or history of heart failure
9) gastrointestinal ulcer or bleeding
10) previous hemoptysis
11) Peritoneal metastases at image
12) Clinical or radiological evidence of CNS metastases
13) Current or previous (within the last 6 months) history of GI perforation
14) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study
15) ongoing treatment with anticoagulant
16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval
17) Under continuous steroid administration
18) decision of unsuitable for this study by the investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiji Koda

Organization

Teikyo University Chiba Medical Center

Division name

Surgery

Zip code


Address

3426-3 Anesaki, Ichihara City, Chiba 2990111, Japan

TEL

0436621211

Email

k-koda@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Yamada

Organization

Nippon medical school hospital

Division name

Digestive Surgery

Zip code


Address

1-1-5 Sendagi, Bunkyo-Ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

y-tak@nms.ac.jp


Sponsor or person

Institute

Teikyo University Chiba Medical Center

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

帝京大学ちば総合医療センター
日本医科大学付属病院


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 01 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

Preinitiation

Date of protocol fixation

2016 Year 05 Month 18 Day

Date of IRB


Anticipated trial start date

2016 Year 06 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

2016 Year 05 Month 24 Day

Last modified on

2016 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025859


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name