UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001743
Receipt number R000002102
Scientific Title Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer
Date of disclosure of the study information 2009/03/02
Last modified on 2011/11/13 21:32:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer

Acronym

Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC

Scientific Title

Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer

Scientific Title:Acronym

Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC

Region

Japan


Condition

Condition

inoperable stage III non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of high-dose thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy for inoperable stage III non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

2-year survival rate

Key secondary outcomes

Response rate, overall survival, incidence of toxicity


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

Cisplatin 80mg/m2 on day 1 + vinorelbine 20mg/m2 on days 1 and 8, repeated every 4 weeks for 4 cycles,
Thoracic radiotherapy 72 Gy/36 fractions

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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

1. a histological or cytological diagnosis of NSCLC; 2. inoperable clinical stage III; 3. no prior treatment; 4. measurable disease; 5. the percent volume of the normal lung receiving 20 Gy or more (V20) equal to or less than 30%; 6. age between 20 and 74 years; 7. Performance Status of 0 - 1; 8. adequate organ function; and 9. written informed consent.

Key exclusion criteria

1. malignant pleural or pericardial effusion; 2. contralateral hilar lymph node metastasis, intralobular metastasis or lymphangitis carcinomatosa; 3. serious concomitant medical illness; 4. synchronous active malignancies; 5. history of chemotherapy or thoracic radiotherapy; 6. pregnancy or breast feeding.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohide Tamura

Organization

National Cancer Center Hospital

Division name

Division of Internal Medicine and Thoracic Oncology

Zip code


Address

Tsukiji 5-1-1, Chuo-ku, Tokyo

TEL

03-3542-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ikuo Sekine

Organization

National Cancer Center Hospital

Division name

Division of Internal Medicine and Thoracic Oncology

Zip code


Address

Tsukiji 5-1-1, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL


Email

isekine@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hyogo Cancer Center
KKR Sapporo Medical Center
National Hospital Organization Hokkaido Cancer Center
Tochigi Cancer Center

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

2009 Year 03 Month 02 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

Suspended

Date of protocol fixation

2009 Year 01 Month 13 Day

Date of IRB


Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2014 Year 02 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

2009 Year 03 Month 01 Day

Last modified on

2011 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name