UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000132
Receipt number R000000194
Scientific Title Phase I study of S-1 with concurrent thoracic radiation therapy for elderly inoperable locally advanced non-small-cell lung cancer
Date of disclosure of the study information 2005/09/12
Last modified on 2015/01/08 18:16:05

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Basic information

Public title

Phase I study of S-1 with concurrent thoracic radiation therapy for elderly inoperable locally advanced non-small-cell lung cancer

Acronym

S-1 with radiotherapy for elderly locally advanced non-small-cell lung cancer

Scientific Title

Phase I study of S-1 with concurrent thoracic radiation therapy for elderly inoperable locally advanced non-small-cell lung cancer

Scientific Title:Acronym

S-1 with radiotherapy for elderly locally advanced non-small-cell lung cancer

Region

Japan


Condition

Condition

Elderly inoperable locally advanced non-small-cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective is to determine the maximum-tolerated doses and the recommended dose of S-1 when combined with concurrent thoracic radiotherapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

maximum-tolerated doses and the recommended dose for phase II

Key secondary outcomes

response rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 with concurrent thoracic radiation therapy

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

76 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Histologically and/or cytologically proven NSCLC
No prior surgery, chemotherapy, or radiotherapy
Age > 75
Unresectable stage IIIA or IIIB
ECOG performance status 0 or 1
Measurable disease
Ample bone marrow, lung, hepatic, and renal function
Signed informed consent

Key exclusion criteria

Involvement of contralateral hilar node, dissemination to pleura/pericardium, or malignant pleural/pericardial effusion
Active concomitant malignancy
History of chemotherapy or thoracic radiotherapy for previous malignancy
Interstitial pneumonia
Unstable angina, recent myocardial infarction
Uncontrolled diabetes
Severe active infection
Other severe complications
Judging of inappropriate condition for this study by physician.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsune Tanimoto

Organization

Okayama University Hospital

Division name

Hematology, Oncology, Respiratory Medicine

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558

TEL

086-235-7227

Email



Public contact

Name of contact person

1st name
Middle name
Last name Nagio Takigawa

Organization

Okayama Lung Cancer Study Group Coordinating Office

Division name

Department of Respiratory Medicine, Okayama University Hospital

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558

TEL

086-235-7227

Homepage URL


Email

ntakigaw@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama Lung Cancer Study 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 09 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


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

2005 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2005 Year 09 Month 01 Day

Last follow-up date

2011 Year 12 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 08 Day

Last modified on

2015 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000194


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name