UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007189 |
|---|---|
| Receipt number | R000008458 |
| Scientific Title | A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/08/01 10:39:58 |
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Basic information
Public title
A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer
Acronym
A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer.
Scientific Title
A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer
Scientific Title:Acronym
A Phase II trial of TS-1 Switch Maintenance Therapy for non-small cell lung cancer.
Region
| Japan |
Condition
Condition
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 of this study is to compare the efficacy and safety of TS-1 as maintenance therapy in patients without progressive disease after receiving treatment with standard chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
Adherence at four course, safety, QOL,
quality adjusted progression free year, proportion of the second-line therapy
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
TS-1 is given in a dose of 40-60 mg/m2 (adjusted to body surface area) twice daily (morning and evening) for 14 consecutive days followed by a 7-day rest. This 3-week period is regarded as one cycle. Treatment is repeated until termination criteria
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirned advanced non-small-cell lung cancer (NSCLC)
2)stage IV or postoperative recurrence patients
3)more than 20 years old
4)Patients previously treated with platinum- based chemotherapy for four cycles and except PD cases
5)ECOG PS 0-1
6)Adequate organ function
7)Signed informed consent
8)patients who can take orally
Key exclusion criteria
1)With fruolouracil based chemotherapy
2)with EGFR TKI therapy
3)patients who will take bevacizumab maintenance therapy
4)Symptomatic brain metastases
5)Pleural effusion, peritoneal fluid, and pericardial fluid
6)Suffers from an infectious disease to need antibiotic treatment
7)Watery diarrhea
8)Serious complications
9)Active concomitant malignancy
10)Pregnancy, breast feeding or wish of future bearing
11)Mental disease or psychotic manifestation
12)History of hypersensitivity against UFT
13) Concomitant therapy with flucytocine
14)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kasahara |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kasahara |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Non
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
金沢大学附属病院 厚生連高岡病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 01 | 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
patients are recruting.
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2012 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008458
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| Registered date | File name |
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| Registered date | File name |
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