UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000097
Receipt number R000000146
Scientific Title A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2005/08/31
Last modified on 2015/08/31 15:35:39

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Basic information

Public title

A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer

Acronym

A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer

Scientific Title

A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer

Scientific Title:Acronym

A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer

Region

Japan


Condition

Condition

ECOG PS2 patients with advanced non-small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of carboplatin and paclitaxel versus gemcitabine and vinorelbine in PS2 patients with advanced NSCLC in a randomized phase II study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

One-year survival rate

Key secondary outcomes

Response rate, time to progression, safety,QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Carboplatin and paclitaxel

Interventions/Control_2

Gemcitabine and vinorelbine

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically or cytologically proven NSCLC with no prior chemotherapy
2. Stage IIIB with malignant pleural or pericardial effusion, stage IV, or recurrent disease after prior surgery or radiotherapy
3. Measurable or evaluable disease;
4. ECOG performance status of 2
5. Life expectancy ≥3 months
6. Age ≥18 years
7. Adequate baseline organ function:
Neutrophile ≥1,500/mm3; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤5 times of the institutional upper limit; total bilirubin ≤1.5 mg/dl; serum creatinine ≤1.5 mg/dl or 24-hour creatinine clearance ≥60 ml/min
8. Signed informed consent

Key exclusion criteria

1. Prior radiotherapy to evaluable disease unless subsequent progression at that site
2. Prior brain metastases if not clinically stable after surgery and/or radiotherapy
3. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <6 months before enrollment or congestive heart failure
4. Active concomitant malignancy requiring treatment.
5. Uncontrolled serious active infection
6. Pre-existing grade 2 neuropathy
7. Pregnancy or lactation

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Saito, M.D.

Organization

Aichi Cancer Center Aichi Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan.

TEL

0564-21-6251

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address

18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan.

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

None

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 08 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/21293243

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

2001 Year 04 Month 14 Day

Date of IRB


Anticipated trial start date

2001 Year 07 Month 01 Day

Last follow-up date

2006 Year 09 Month 01 Day

Date of closure to data entry

2007 Year 04 Month 01 Day

Date trial data considered complete

2007 Year 04 Month 01 Day

Date analysis concluded

2007 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 31 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000146


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name