UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012786
Receipt number R000014925
Scientific Title Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab for elderly non-squamous non-small-cell lung cancer. (TORG1323)
Date of disclosure of the study information 2014/01/11
Last modified on 2020/04/21 13:56:19

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Basic information

Public title

Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab
for elderly non-squamous non-small-cell lung cancer. (TORG1323)

Acronym

Randomized phase II study of DOC + BEV or PM +BEV for elderly non-squamous NSCLC. (TORG1323)

Scientific Title

Randomized phase II study of docetaxel + bevacizumab or pemetrexed + bevacizumab
for elderly non-squamous non-small-cell lung cancer. (TORG1323)

Scientific Title:Acronym

Randomized phase II study of DOC + BEV or PM +BEV for elderly non-squamous NSCLC. (TORG1323)

Region

Japan


Condition

Condition

Advanced 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 docetaxel+bevacizumab or pemetrexed+bevacizumab for previously untreated elderly non-squamous non-small-cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival (central review)

Key secondary outcomes

Safety
Progression-free survival ( attending investigator's assessment)
Response rate(RR)
Overall survival(OS)
Time to treatment failure
QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

docetaxel + bevacizumab

Interventions/Control_2

pemetrexed + bevacizumab

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)Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
2)Clinical stage IIIB(not amenable to curative radiation),VI or recurrent disease
3)ECOG performance status 0-1
4)Patients who have at least one or more measurable lesion by RESIST(Version1.1)
5)Aged 75<=
6)Adequate organ funcution
7)Interval
(1)Radiation therapy
More than 2 weeks after the last radiation therapy for nonthoracic region or brainmetastasis resion
(2)Operation
More than 4 weeks after the last operation
More than 2 weeks after the last pleurodesis or thoracic cavity drainage.
More than 8 weeks after the last operation with brain metastasis
8)Estimated life expectancy at least 12 weeks
9)Written informed consent

Key exclusion criteria

1)History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL within 12 weeks prior to registration
2)Symptomatic brain metastasis
3)Current or recent(within 10 days prior to first dose of bevacizumab) use of aspirin(>325mg/day), clopidogrel(>75mg/day), or current or recent(within 10 days prior to first dose of bevacizumab) use of anticlotting drug or thrombolytic agent
4)hypertension(blood pressure systolic>150mmHg and/ or diastolic >100mmHg) with or without treatment
5)Active double malignancies
6)Radiotherapy to lung field or mediastinum
7)Evidence of tumor invading a perihilar blood vessel on imaging
8)Evidence of tumor invading segmental bronchus or subsegmental bronchus on bronchofiberscopy
9)Having a history or serious complications
10)Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration
11)Psychotic disorder
12)Uncontrolled ascites, pleural effusion or cardiac effushion
13)Double cancer less than 5 years disease free period
14)Severe drug allergy
15)ctive hepatic diseases
16)A past hypersensitive for polysorbate

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsu Shinkai

Organization

Shonan east general hospital

Division name

Cancer center

Zip code


Address

500, Nishikubo, Chigasaki, Kanagawa

TEL

0467-83-9111

Email

teshinkai@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Naoyuki Nogami, Toshiyuki Kozuki

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Department of thoracic oncology

Zip code


Address

160 Kou Minamiumemoto-machi, Matsuyama, Ehime 791-0280

TEL

089-999-1111

Homepage URL


Email

nnogami@shikoku-cc.go.jp


Sponsor or person

Institute

Thoracic Oncology Research Group

Institute

Department

Personal name



Funding Source

Organization

CHUGAI PHARMACUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 11 Day


Related information

URL releasing protocol

-

Publication of results

Published


Result

URL related to results and publications

http://tlcr.amegroups.com/article/view/38238

Number of participants that the trial has enrolled

103

Results

Overall, 103 patients (DB: n=51; PB: n=52) were enrolled. In the DB and PB arms, median ages were 78 and 79 years, respectively; median PFS were 6.1 and 4.6 months, respectively [HR, 1.03; 95% CI, 0.66-1.61]; and response rates were 43%, and 40%. Grade >=3 leukopenia, neutropenia, and fatigue incidences were significantly higher in the DB arm. Febrile neutropenia incidence did not differ significantly. QoL analysis revealed less deterioration in the PB arm.

Results date posted

2020 Year 04 Month 21 Day

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

Completed

Date of protocol fixation

2013 Year 12 Month 19 Day

Date of IRB

2014 Year 02 Month 17 Day

Anticipated trial start date

2014 Year 02 Month 03 Day

Last follow-up date

2017 Year 09 Month 30 Day

Date of closure to data entry

2017 Year 11 Month 30 Day

Date trial data considered complete


Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 08 Day

Last modified on

2020 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014925


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name