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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002162
Receipt No. R000002647
Scientific Title A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.
Date of disclosure of the study information 2009/07/03
Last modified on 2009/07/03

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Basic information
Public title A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.
Acronym A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.(HTCARP-0001)
Scientific Title A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.
Scientific Title:Acronym A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.(HTCARP-0001)
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine maximum tolerated dose and recommended dose of TS-1+RT for elderly patients of Non-small cell lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes To determine maximum tolerated dose and recommended dose of TS-1+RT for elderly patients of Non-small cell lung cancer.
Key secondary outcomes Adverse events for treatment (56days) or after 56days, Response rate (RR), Overall survival (OS), Disease control rate, Disease free survival (DFS)

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 Radiation: using 6-10MV X-ray, daily 2Gy, 5 days/week until 64Gy.
TS-1: TS-1 (each level) is administered orally on days 1-14 every 21 days.

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
75 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed Non-small cell lung cancer
2) Measurable disease
3) Stage II-IIIB
4) Performance Status (ECOG) 0-2
5) more than 75 years old
6) never treatment for Non-small cell lung cancer
7) Adequate organ functions
8) Oral intake is possible
9) Written informed consent
Key exclusion criteria 1 patient with marked fever and suspected infection
2 patient has dreaded complication
3 concomittant active malignancy
4 needing teratment pleulal effusion and hydroperitoneum syndrome
5 patient of the pericardium water retension syndrome
6 patient has chicken pox
7 Serious neuropathy
8 Anarmnesis of drug allergy
9 Severe bone marrow suppression
10 serious renal function disturbance
11 serious liver function disturbance
12 taking other fluoropyrimidime
13 Under treatment with flucytosine
14 Not suitable for participating in the study for any othe reason
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Nagata
Organization Hiroshima university
Division name Department of Radiology
Zip code
Address 1-2-3,kasumi, minami-ku, Hiroshima-shi, Hiroshima 730-8551, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima university
Division name Department of Radiology
Zip code
Address
TEL 082-257-1545
Homepage URL
Email

Sponsor
Institute Hiroshima Radiation Oncology Study Group
Institute
Department

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
2009 Year 07 Month 03 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 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 07 Month 03 Day
Last modified on
2009 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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