UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000087
Receipt number R000000138
Scientific Title To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC
Date of disclosure of the study information 2005/08/29
Last modified on 2015/08/31 15:33:26

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Basic information

Public title

To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC

Acronym

To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC

Scientific Title

To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC

Scientific Title:Acronym

To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC

Region

Japan


Condition

Condition

unresectable stage III NSCLC

Classification by specialty

Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Survival

Key secondary outcomes



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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

arm A : The chemotherapy regimen consist of Cisplatin 80mg/m2 on day1 AND 29, Vindesine 3mg/m2 on day1,8, 29, and 36, Mitomycin 8mg/m2 on day1 and 29. The concurrent radiation consists of two, 30 gray courses separated by a 7-day rest period. Patients receive 2 courses of chemotherapy consist of Cisplatin, Vindesine, and Mitomycin as consolidation chemotherapy.

Interventions/Control_2

arm B: The chemotherapy regimen consists of Irinotecan 20mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Irinotecan and Carboplatin as consolidation chemotherapy.

Interventions/Control_3

arm C: The chemotherapy regimen consists of Paclitaxel 40mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Paclitaxel and Carboplatin as consolidation chemotherapy.

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


Not applicable

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

All patients had histologocally or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.

Key exclusion criteria

The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection.

Target sample size

450


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Uejima

Organization

Rinku General Medical center

Division name

Department of Pulmonary Medicine

Zip code


Address

2-23, Rinku-Orai-Kita, Izumisano, Osaka 598-8577, Japan

TEL

0724-69-3111

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

2-23, Rinku-Orai-Kita, Izumisano, Osaka 598-8577, 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 29 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=20625120

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 07 Month 21 Day

Date of IRB


Anticipated trial start date

2001 Year 10 Month 01 Day

Last follow-up date

2006 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2010 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 29 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=R000000138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name