UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011095
Receipt number R000012669
Scientific Title A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer
Date of disclosure of the study information 2013/07/02
Last modified on 2018/07/06 14:53:24

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Basic information

Public title

A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer

Acronym

Phase II study of CBDCA/PEM/BEV in elderly NSCLC

Scientific Title

A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer

Scientific Title:Acronym

Phase II study of CBDCA/PEM/BEV in elderly NSCLC

Region

Japan


Condition

Condition

Non-squamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of the combination of CBDCA/PEM/BEV in elderly patients with non-sq NSCLC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CBDCA+PEM+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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) In histological or cytological diagnosis, diagnosis of the non-squamous and
non-small cell lung cancer is obtained
2) More than 75 years old at the time of the agreement acquisition
3) Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 0-1
4) With the measurable disease based on Response Evaluation Criteria in solid Tumors (RECIST) v. 1.1
5) There is not systemic chemotherapy history for non-squamous cell and small cell carcinoma, expect UFT for adjuvant therapy or therapy for pleurodesis and first line of EGFR-TKI or Crizotinib
6) With adequate organ function within one week before study entry
7) The expected survival more than 90 days from the enrollment
8) An agreement by the document from a patient

Key exclusion criteria

1) The case that there is previous treatment history
2) With the active double primary cancer
3) With the pleural effusion or pericardial effusion to need drainage
4) With the metastatic brain tumor to need treatment, such as radiotherapy or steroid
5) History of active hemoptysis with 2,5 ml or more
6) The case that a hemorrhage risk is high
a) With the necessity of the administration of anticoagulant and antiplatelet agent
b) With the the tumor invasion to great vessels
c) With the cavity lesion
7) With the following complication or past history
a) With the merger or history of cerebrovascular disease to need treatment
b) With the history of perforation gastrointestinal, fistula, diverticulitis
c) With the diarrhea, paresis of intestine, ileus
d) With the merger or history of angina or myocardial infarction, cardiac failure to need treatment
e) With the uncontrol diabetes
f) With the interstitial pneumonia
g) With the uncontrol infectious disease
h) With the history of serious drug allergy
i) With the uncontrol hypertension even if taking the hypotensive drug
8) With the mental disease
9) The patient whom attending physician judged to be inadequate to perform the
study treatment safely

Target sample size

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Yamada

Organization

Department of Internal Medicine, Kurume University School of Medicine

Division name

Division of Respirology, Neurology, and Rheumatology

Zip code


Address

67 Asahi-machi, Kurume, Fukuoka

TEL

0942-31-7560

Email

kayamada@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Yamada

Organization

Department of Internal Medicine, Kurume University School of Medicine

Division name

Division of Respirology, Neurology, and Rheumatology

Zip code


Address

67 Asahi-machi, Kurume, Fukuoka

TEL

0942-31-7560

Homepage URL


Email

kayamada@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kurume University School of Medicine

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

久留米大学病院(福岡県)、九州医療センター(福岡県)


Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

2013 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2013 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

2013 Year 07 Month 02 Day

Last modified on

2018 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name