UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009275
Receipt No. R000010895
Scientific Title PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Date of disclosure of the study information 2012/11/06
Last modified on 2012/11/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Acronym PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Scientific Title PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Scientific Title:Acronym PhaseII study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Region
Japan

Condition
Condition Non Squamous Non Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase II study of maintenance S-1 after chemotherapy with platinium+pemetrexed in advanced nonsquamous NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Overall Survival,
Response Rate,
Safety

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 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)Patients previously treated with platinum- based chemotherapy for four cycles and except PD cases
4)more than 20 years old
5)ECOG PS 0-2
6)Measurable lesion
7)Adequate organ function
8)patients who can take orally
9)Signed informed consent
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis on chest X-ray
2) History of serious drug allergy
3)Patients with active double cancer 4)Patients with pleural or pericardial effusion ,or ascites
5)Being treated with flucytosine.
6) History of serious infection
7)History of HBs antigen
8)Patients with significant complications
a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months
b)Uncontrolled diabetes or hypertension
c)Current severe infection, or suspicious of severe infection
d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella)
9 )Symptomatic brain metastases
10)Patients with pregnancy or lactation
11)patients whom it is judged to have difficulty in participation in study because of psychosis or neurologic disease
12)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size 22

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name TAKASHI YOKOI
Organization Kansai Medical University Hirakata
Hospital
Division name Respiratory medicine
Zip code
Address 2-3-1 Shin-machi, Hirakata-shi, Osaka 573-1191 JAPAN
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Kansai Medical University Hirakata Hospital
Division name Respiratory medicine
Zip code
Address
TEL
Homepage URL
Email yokoit@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
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 関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 06 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 06 Day
Last modified on
2012 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010895

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.