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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009345
Receipt No. R000010976
Scientific Title Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)
Date of disclosure of the study information 2012/11/16
Last modified on 2017/11/20

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Basic information
Public title Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)
Acronym Phase II Trial of CBDCA + S-1 for 1st line Elderly NSCLC with Wild Type EGFR (OLCSG1202)
Scientific Title Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)
Scientific Title:Acronym Phase II Trial of CBDCA + S-1 for 1st line Elderly NSCLC with Wild Type EGFR (OLCSG1202)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The present study was planned with the objective of investigating the combination of carboplatin and S-1 in the treatment of previously untreated elderly patients with advanced non-small-cell lung cancer. This study is designed as a phase II study of assessment of the efficacy and tolerability.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Progression Free Survival, Overall Survival, Quality of Life, Adverse Event, Effects of complication, Compliance with Treatment

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 Four cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off) followed by maintenance S-1 monotherapy in 4-week cycles until progression disease
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients
2) Patients who have measurable lesion or evaluable lesion by RECIST
3) Patients with Chemo-naive patients Stage three/four without any indications for radiotherapy
4) Patients aged over 70 years old
5) ECOG PS 0-2
6) Patients who have measurable lesion or evaluable lesion by RECIST
7) Adequate bone mallow function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as
WBC >= 3,000/mm3
Neu >= 1,500/mm3
Plt >= 150,000/mm3
Hb >= 9 g/dL
8) Adequate liver function
T.Bil <= 1.5 mg/dL
AST/ALT <= 2.5 * upper limit of normal
9) Adequate renal function
Serum Cr <= upper limit of normal.
10) Adequate pulmonary function
PaO2 >= 60 Torr or SpO2 >= 90 % (both at rest and room air)
11) Patients who underwent palliative radiation therapy within one week were excluded
12) Patients who are able to take orally
13) Written informed consent from the patients
Key exclusion criteria 1) Patients with brain metastases with the clinical symptoms
2) Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity
3) Patients who underwent radiation therapy within one weeks (a palliative radiation therapy to the lesion, e.g. bone metastasis, was excepted from this exclusion)
4) Patients with a history of severe drug allergy
5) Pregnancy, breast feeding or wish of future bearing
6) Patients with severe complication
Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
History of severe heart disease (uncontrollable arrhythmia, uncontrollable angina pectoris, congestive heart failure, etc. within 3 months)
Uncontrollable diabetes mellitus
Patients with severe infection
Patients has pleural effusion, pericardial effusion and ascites to be treated
7) Patients who need to be treated by radiotherapy in an urgent
8) concomitant therapy with other pyrimidine fluoride antineoplastic agents
9) concomitant therapy with warfarin
10) concomitant therapy with dabigatran etexilate
11) Principal investigator cases that are deemed inappropriate
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Kiura
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7227
Email kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Hotta
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7227
Homepage URL
Email khotta@md.okayama-u.ac.jp

Sponsor
Institute Okayama Lung Cancer 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) None

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
2012 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.lungcancerjournal.info/article/S0169-5002(17)30471-3/abstract
Number of participants that the trial has enrolled
Results
Carboplatin plus S-1 had favorable efficacy and tolerable toxicity for the elderly with NSCLC. This study met the predesigned primary endpoint, and the regimen seems to be a potent treatment option. Low TP expression in tumors might serve as a  predictive maker of a better DCR. We need to conduct further studies to evaluate whether this combination is superior to the standard first-line treatment for the elderly.
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 Main results already published
Date of protocol fixation
2012 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 16 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 16 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010976

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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