UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008928
Receipt number	R000010462
Scientific Title	A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
Date of disclosure of the study information	2012/09/19
Last modified on	2014/11/11 16:12:36

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Basic information

Public title

A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

non-squamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To assess efficacy in elderly patients with previously untreated stageIII/VI or postoperative recurrence non-squamous non-small cell lung cancer treated with pemetrexed monotherapy or pemetrexed plus carboplatin combined therapy followed by maintenance pemetrexed therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Progression Free Survival (PFS)

Key secondary outcomes

Response rate (RR), Disease control rate (DCR)
overall survival (OS), Safety

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Four cycles of Pemetrexed+ Carboplatin followed by maintenance Pemetrexed in 3 weeks cycles until progression disease

Interventions/Control_2

Four cycles of Pacritaxel followed by maintenance Pemetrexed in 3 weeks cycles until progression disease

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed nonsqamous non-small cell lung cancer
2) Stage III/VI without any indications for radiotherapy, or recurrent disease after surgery
3) No prior chemotherapy or oral postoperative adjuvant chemotherapy stopped more than one month before
4) Patients who have measurable lesion
5) ECOG PS 0-1
6) Patients aged 75-84
7) No prior chemotherapy for primary lesion
8) No prior chemotherapy nor radiation therapy for other cancers
9) Patients are excepted to live at least 3 months
10) Adequate organ function, evaluated within 14 days before enrollment
WBC >=4,000/mm3
Neu >=2,000/mm3
Plt >=100,000/mm3
Hb>=9.0g/dl
AST<=100IU/l, /ALT<=100IU/l
T.Bil<=2.0mg/dl
sCr<=1.0mg/dl
SpO2>= 90% or PaO2>= 60torr
11) Written informed consent from the patients

Key exclusion criteria

1) Apparent interstitial pneumonia or pulmonary fibrosis detectable on Chest CT
2) Serious complications as follows;
1.Uncontrollable angina pectoris, acute myocardial infarction or congestive heart failue, etc within 1 year
2.Uncontrollable diabetes mellitus and hypertenson
3.Active infectious disease
4. intestinal paralysis or intestinal obstruction
5. Other Serious complications
3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment
4) symptomatic brain metastasis
5) SVC syndrome
6) Active double cancer
7) Pregnancy, breast feeding and suspected or wish of pregnancy
8) Patients who have serious drug hypersensitivity reaction
9) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms
10) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Target sample size

100

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Naohiko Inase

Organization

Tokyo Medical and Dental university

Division name

Department of Integrated Pulmonology

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name Hiroyuki Sakashita

Organization

Tokyo Medical and Dental university

Division name

Department of Integrated Pulmonology

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

Homepage URL

Email

Sponsor or person

Institute

Yushima Lung Cancer Oncology Group(YLOG)

Institute

Department

Personal name

Funding Source

Organization

Department of Integrated Pulmonology, Tokyo Medical and Dental university

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 19 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

2010 Year 08 Month 27 Day

Date of IRB

Anticipated trial start date

2010 Year 12 Month 24 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

2012 Year 09 Month 15 Day

Last modified on

2014 Year 11 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010462

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name