UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006139
Receipt number R000007260
Scientific Title Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer.
Date of disclosure of the study information 2011/08/10
Last modified on 2012/03/09 12:57:53

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Basic information

Public title

Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer.

Acronym

Phase II Study of PEM/CBDCA Followed by PEM for elderly Non-squamous and Non-small Cell Lung Cancer.

Scientific Title

Phase II Study of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous and Non-small Cell Lung Cancer.

Scientific Title:Acronym

Phase II Study of PEM/CBDCA Followed by PEM for elderly Non-squamous and Non-small Cell Lung Cancer.

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 efficacy and safety of Pemetrexed in Combination with Carboplatin Followed by Pemetrexed Maintenance Therapy for Elderly Advanced Non-squamous Non-small Cell Lung Cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

progression free survival

Key secondary outcomes

response rate, safety, overall survival, 1 year survival


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

PEM/CBDCA

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Histologically proven non-squamous non-small cell lung cancer
(2)Patient who has measurable lesion by RECIST
(3)Stage 3B/4 NSCLC
(4)ECOG performance status: 0-1
(5)Aged>=70 years
(6)No chemotherapy, radiotherapy, immunotherapy as prior therapy as for NSCLC
(7)Adequate organ functions
(8)Life expectancy >= 3 months
(9)Written informed consent

Key exclusion criteria

(1)Patients with other clinically significant complications; for example, uncontrollable diabetes and hypertension.
(2)Active severe infections.
(3)Patients with symptomatic brain metastasis .
(4)Patients with massive pleural or pericardial effusion.
(5)With prior unapproved drugs or investigational new drugs.
(6)Not appropriate to receive the folic acid and vitamin B12 formulation.
(7)With peripheral nerves >= grade 2 at enrollment.
(8)Continues to NSAIDs during this study.
(9)Inappropriate patients for this study judged by the physicians.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Ishii

Organization

Dokkyo Medical University School of Medicine

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code


Address

880 Kitakobayashi, Mibu, Tochigi, Japan

TEL

0282-87-2151

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tochigi Thoracic Oncology Research Organization

Division name

Office

Zip code


Address


TEL


Homepage URL


Email

ishiiysk@dokkyomed.ac.jp


Sponsor or person

Institute

Tochigi Thoracic Oncology Research Organization

Institute

Department

Personal name



Funding Source

Organization

Tochigi Thoracic Oncology Research Organization

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

2011 Year 08 Month 10 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

Enrolling by invitation

Date of protocol fixation

2011 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 08 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

2011 Year 08 Month 09 Day

Last modified on

2012 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name