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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007189
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008458

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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