Unique ID issued by UMIN | UMIN000007433 |
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Receipt number | R000008747 |
Scientific Title | A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma |
Date of disclosure of the study information | 2012/03/02 |
Last modified on | 2012/09/14 16:06:53 |
A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma
CJLSG1102
A Phase II Study of Carboplatin and S-1 Followed by S-1 Maintenance for Patients Who Have Squamous Cell Lung Carcinoma
CJLSG1102
Japan |
Squamous Cell Lung Carcinoma
Pneumology |
Malignancy
NO
The aim of the present study is to assess the effectiveness and safety of maintenance therapy for patients previously untreated non-small cell lung cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
12w-Disease control rate
Overall Survival,
Progression Free Survival,
Ratio of entering to Maintenance Therapy,
Safety,
Quality of Life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin and S-1 followed by S-1 maintenance
20 | years-old | <= |
Not applicable |
Male and Female
1) Better than SD after 4 cycles of S-1 plus carboplatin as initial therapy.
2) ECOG performance status (PS): 0-2
3) Adequate organ function.
1) Active infection or other serious disease condition (poorly controlled diabetes mellitus, cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.).
2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease,pneumoconiosis,active radiation pneumonia,etc.).
3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome.
4) Symptomatic brain metastasis.
5) Grade 2 or higher diarrhea
6) Pregnant or nursing females
7) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
30
1st name | |
Middle name | |
Last name | Ryujiro Suzuki |
Toyohashi Municipal Hospital
Department of Respiratory Medicine
50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.
0532-33-6111
1st name | |
Middle name | |
Last name | Yoshihiro Takeyama |
Toyohashi Municipal Hospital
Department of Respiratory Medicine
50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.
0532-33-6111
Central Japan Lung Study Group (CJLSG)
Central Japan Lung Study Group (CJLSG)
Self funding
JAPAN
NO
Central Japan Lung Study Group (CJLSG)
2012 | Year | 03 | Month | 02 | Day |
Unpublished
Open public recruiting
2012 | Year | 02 | Month | 23 | Day |
2012 | Year | 03 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 02 | Day |
2012 | Year | 09 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008747
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