UMIN-CTR Clinical Trial

Public title

Randomized Phase 2 trial of Individualized Monotherapy based on CYFRA-21-1 serum levels before treatment Versus Pemetrexed Monotherapy in Older Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer and wild-type EGFR tumors

Acronym

Individualized Chemotherapy based on CYFRA-21-1 serum levels in Older Non-Sq NSCLC Patients

Scientific Title

Randomized Phase 2 trial of Individualized Monotherapy based on CYFRA-21-1 serum levels before treatment Versus Pemetrexed Monotherapy in Older Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer and wild-type EGFR tumors

Scientific Title:Acronym

Individualized Chemotherapy based on CYFRA-21-1 serum levels in Older Non-Sq NSCLC Patients

Region

Japan

Condition

Older patients with advanced nonsquamous non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of Pemetrexed in older patients with EGFR mutation negative advanced nonsquamous non-small-cell lung cancer and to study relationships between the efficacy of Pemetrexed in them and CYFRA-21-1 serum level as predictive biomarker.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

6-month progression-free survival rate

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A Pmetrexed(500mg/m2) given on day1 every 3 weeks in case of low CYFRA-21-1 serum level
A Docetaxel(60mg/m2) given on day1 every 3 weeks or Gemcitabine(1,000mg/m2) given on day1, day8 every 3 weeks in case of high CYFRA-21-1 serum level

Interventions/Control_2

B Pmetrexed(500mg/m2) given on day1 every 3 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer
2) No prior chemotherapy
3) Wild type EGFR
4) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease
5) With one or more measurable disease or evaluable disease (RECIST ver.1.1)
6) 75 years of age or older
7) Performamne status of 0 or 1
8) Adequate organ function
9) Life expectancy more than 3 months
10) Written informed consent

Key exclusion criteria

1) Squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
3) History of drug-induced pneumonitis
4) History of poorly controlled pleural effusion,pericardial effusion and ascites
5) No oral supplement of folic acid and no injection of vitamin B12
6) Superior vena cava syndrome
7) Symptomatic brain metastasis
8) Uncontrollable hypertension or diabetes mellitus
9) History of severe heart disease (acute cardiac infarction or unstable angina within 6 months of registration, post-PTCA, post-CABG, sign of heart failure, uncontrollable arrythmia)
10) Severe drug allergy
11) History of active infection
12) Active concomitant cancers
13) Those judged to be not suitable by the attending physician

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshige Yoshioka

Organization

Kurashiki Central Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-1-1, Miwa, Kurashiki, Okayama

TEL

086-422-0210

Email

hirotin@kchnet.or.jp

Name of contact person

1st name
Middle name
Last name	Akihiro Nishiyama

Organization

Kurashiki Central Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-1-1, Miwa, Kurashiki, Okayama

TEL

086-422-0210

Homepage URL

Email

an11901@kchnet.or.jp

Institute

Kyoto Thoracic Oncology Research Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

10

Month

10

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

11

Month

14

Day

Last modified on

2013

Year

11

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014375