UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002162 |
|---|---|
| Receipt number | 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 17:18:50 |
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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
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
Sponsor or person
Institute
Hiroshima Radiation Oncology 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002647
