UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022705
Receipt number R000025658
Scientific Title A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Date of disclosure of the study information 2016/06/12
Last modified on 2019/08/27 22:32:01

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Basic information

Public title

A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy

Acronym

A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer

Scientific Title

A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy

Scientific Title:Acronym

A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and toxicity of TAS-102 and bevacizumab for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Response Rate
Disease control rate
Overall survival
Adverse events


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 plus bevacizumab combination therapy (q4w)
TAS-102: 35mg/m2 BID on days 1-5 and 8-12
Bevacizumab: 5mg/kg on day1 and 15

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) histologically proven colon cancer or rectal cancer (both Kras Wt and MT)
2) Group E : >= 76 years old
Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events
3) with mesurable lesions for RECIST criteria
4) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before)
5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
6) rest period from former therapy
a) more than 4 weeks from an organ resection surgery
b) more than 4 weeks from hormone therapy or immune therapy
c) more than 4 weeks from cytokine or BRM therapy
d) more than 6 weeks from radiation therapy for extensive lesions
7) without any severe complications and limited in the following data
a) neutrophile : 1,500/mm3 <=
b) platelet : 100,000/mm3 <=
c) hemoglobin : 9.0g/dl <=
d) T.bil. : 1.5mg/dl >=
e) AST, ALT : 100 IU/l ( within 2.5 times of normal range of the hospital
f) creatinine : 1.5mg/dl >=
g) urine protein : 1+ >=
h) PT-INR : 1.5 >=
8) patients expected more than 8 weeks survival
9) able to oral intake
10) written with informed consent

Key exclusion criteria

1) with symptoms due to brain metastatis
2) with uncontrolable diarrhea
3) with difficulty on oral intake due to intestinal paralysis or obstruction
4) with infections diseases or febrile condition
5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc)
6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure)
7) pregnant and/or nursing women, or women who expect pregnancy
8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder
9) with a condition intolerance to
medicines in this regimen
10)with a history of some chemotherapy and/or therapy including a VEGF antagonist
11) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction
12) under easy bleeding condition due to some diseases or medicines (except low dose aspirin)
13) with active wounds except reservoir surgery
14) with a history of bloody spit more than 2.5ml
15) with no bowel obstruction
16) with no peritoneum disseimination
17) any other patient whom the physician in charge of the study judges to be unsuitabl

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka medical Center for Cancer and Cardiovascular Diseases

Division name

Clinical Oncology

Zip code


Address

1-3-3, Nakamichi, Higashinari-ku, Osaka

TEL

06-6972-1181

Email

sugimoto-na2@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka medical Center for Cancer and Cardiovascular Diseases

Division name

Clinical Oncology

Zip code


Address

1-3-3, Nakamichi, Higashinari-ku, Osaka

TEL

06-6972-1181

Homepage URL


Email

sugimoto-na2@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka medical Center for Cancer and Cardiovascular Diseases

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

2016 Year 06 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

Terminated

Date of protocol fixation

2016 Year 03 Month 31 Day

Date of IRB

2016 Year 03 Month 31 Day

Anticipated trial start date

2016 Year 06 Month 13 Day

Last follow-up date

2019 Year 03 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 12 Day

Last modified on

2019 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name