UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009345 |
|---|---|
| Receipt number | 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 17:20:21 |
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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
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
khotta@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama Lung Cancer 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)
None
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010976
