UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000112
Receipt number R000000164
Scientific Title Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Date of disclosure of the study information 2005/09/04
Last modified on 2005/09/04 22:14:27

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Basic information

Public title

Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer

Acronym

Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer

Scientific Title

Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer

Scientific Title:Acronym

Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer

Region

Japan


Condition

Condition

non small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of carboplatin and gemcitabine in elderly patients with advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

response rate

Key secondary outcomes



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

day 1: CBDCA 4AUC GEM 1000mg/m2
day 8: GEM 1000mg/m2

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

Patients with histologically or cytologically confirmed NSCLC who were 70 years or older at diagnosis, had measurable disease on thoracic computed tomography (CT) scans, and had not previously received chemotherapy were eligible for enrollment in the study. An additional requirement was that the disease was inoperable as a result of substantial comorbidity, impairment of respiratory function, or anatomic contraindication. Patients who relapsed after complete tumor resection or in whom resection was incomplete were also eligible. Further entry criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as well as adequate bone marrow (leukocyte count, 4000 to 12,000/µL; hemoglobin concentration, >9.0 g/dL; platelet count, >100,000/µL), renal (serum creatinine concentration, <1.5 mg/dL), hepatic (serum aspartate aminotransferase and alanine aminotransferase , <1.5 times the upper limit of the normal range; serum total bilirubin, <1.5 mg/dL), and pulmonary (PaO2, >70 torr) function.

Key exclusion criteria

Individuals with active infection, severe heart disease, active concomitant malignancy, or pleural or pericardial effusion requiring drainage were excluded.

Target sample size

55


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Isamu Okamoto

Organization

Kinki University School of Medicine

Division name

Department of Medical Oncology,

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama,

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Ji-ichiro Sasaki

Organization

Kumamoto University School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address


TEL


Homepage URL


Email

saji@gpo.kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kumamoto University School of Medicine

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

2005 Year 09 Month 04 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

Date of protocol fixation

2004 Year 10 Month 15 Day

Date of IRB


Anticipated trial start date

2004 Year 10 Month 01 Day

Last follow-up date

2006 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 09 Month 04 Day

Last modified on

2005 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000164


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name