UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003755
Receipt number R000004549
Scientific Title A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
Date of disclosure of the study information 2010/06/15
Last modified on 2012/12/15 01:19:19

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Basic information

Public title

A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

Acronym

A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

Scientific Title

A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

Scientific Title:Acronym

A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

Region

Japan


Condition

Condition

Non-squamous non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

One year survival

Key secondary outcomes

Evaluation of safety,
Objective response rate,
Progression Free 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

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

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent)
2) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST
3) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last dosage of adjuvant chemotherapy
4) Patients aged 20 years or older
5) Karnofsky performance status 70-100
6) Adequate organ function, evaluated within 14 days before enrollment as;
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 100,000/mm3
Hb >= 9.5 g/dL
AST/ALT <= x 3 upper limit of normal range
T. Bil <= 1.5 g/dL
Ccr >= 60mL/min or sCr <= 1.2mg/dL
SpO2 >= 93% as room air
7) Excepted to live over 3 months after administration day
8) Written informed consent from the patients

Key exclusion criteria

Patients with at least one of the following conditions are ineligible
1) squamous cell carcinoma
2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
3) Pleural effusion, pericardial effusion and ascites to need treatment
4) Patients unable to take or unsupplied with folic acid and vitamin B12
5) Severe renal function disorder
6) SVC syndrome
7) Brain metastases with neurological symptoms
8) Active double cancer
9) Uncontrollable diabetes mellitus and hypertenson
10) Liver cirrhosis by image findings or laboratory examinations
11) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.)
12) Pregnancy, breast feeding and suspected pregnancy
13) History of grave drug allergic reaction
14) Acute inflammatory disease
15) An agreement is not obtained for support therapy such as transfusion etc
16) Having the bleeding tendency which is clinically apparent
17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kijima

Organization

Osaka University Hospital

Division name

Dept. of Respiratory Medicine

Zip code


Address

2-2 Yamada-oka, Suita 565-0871, Osaka, Japan

TEL

06-6879-3833

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takashi Kijima

Organization

Osaka University Hospital

Division name

Dept. of Respiratory Medicine

Zip code


Address

2-2 Yamada-oka, Suita 565-0871, Osaka, Japan

TEL

06-6879-3833

Homepage URL


Email

tkijima@imed3.med.osaka-u.ac.jp


Sponsor or person

Institute

Dept. of Respiratory Medicine,
Osaka University Hospital

Institute

Department

Personal name



Funding Source

Organization

Dept. of Respiratory Medicine,
Osaka University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

OULCSG

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

2010 Year 06 Month 15 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

Completed

Date of protocol fixation

2009 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2012 Year 11 Month 30 Day

Date of closure to data entry

2012 Year 11 Month 30 Day

Date trial data considered complete

2012 Year 11 Month 30 Day

Date analysis concluded

2012 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2010 Year 06 Month 14 Day

Last modified on

2012 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004549


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name